Trial Outcomes & Findings for Study of Epacadostat (INCB024360) Alone and In Combination With Pembrolizumab (MK-3475) With Chemotherapy and Pembrolizumab Without Chemotherapy in Participants With Advanced Solid Tumors (MK-3475-434) (NCT NCT02862457)
NCT ID: NCT02862457
Last Updated: 2022-08-19
Results Overview
A DLT was defined as the occurrence of any treatment-emergent adverse event occurring up to and including Study Day 7 for Part A Cohort 1 or Day 21 for Part A Cohort 2 and Part B. The following criteria defined DLTs: Grade (G) 4 thrombocytopenia; G4 neutropenia (despite optimal supportive care in Part B) lasting \>1 week; febrile neutropenia (only if considered clinically significant in Part B); G4 toxicity; G3 laboratory abnormality lasting \>1 week: G3 toxicity excluding nausea or vomiting controlled within 72 hours, rash in the absence of desquamation, no mucosal involvement, does not require systemic steroids, and resolves to G1 by the next scheduled dose of pembrolizumab or 14 days; G2 or higher episcleritis, uveitis, or iritis; unable to receive 75% of epacadostat or 1 dose of pembrolizumab during the DLT observation period because of toxicity, even if the toxicity does not meet DLT criteria; or \>2 week delay in initiating Cycle 2 due to toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Up to Day 7 for Part A Cohort 1; up to Day 21 for Part A Cohort 2 and Part B
Results posted on
2022-08-19
Participant Flow
Participant milestones
| Measure |
Part A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 100 mg
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
7
|
6
|
6
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
2
|
7
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
4
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Part A Cohort 1: Epacadostat 25 mg
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 100 mg
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
3
|
2
|
3
|
0
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of Epacadostat (INCB024360) Alone and In Combination With Pembrolizumab (MK-3475) With Chemotherapy and Pembrolizumab Without Chemotherapy in Participants With Advanced Solid Tumors (MK-3475-434)
Baseline characteristics by cohort
| Measure |
Part A Cohort 1: Epacadostat 25 mg
n=3 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 100 mg
n=3 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=3 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
n=7 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 7.8 • n=99 Participants
|
71.0 years
STANDARD_DEVIATION 4.6 • n=107 Participants
|
62.0 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
67.5 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 7.3 • n=31 Participants
|
68.0 years
STANDARD_DEVIATION 3.8 • n=30 Participants
|
61.0 years
STANDARD_DEVIATION 13.4 • n=3 Participants
|
63.9 years
STANDARD_DEVIATION 8.6 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
22 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
34 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
34 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to Day 7 for Part A Cohort 1; up to Day 21 for Part A Cohort 2 and Part BPopulation: All participants in Parts A and B who received ≥1 dose of study treatment and who completed all safety evaluations in the pre-specified time frame for DLT analysis
A DLT was defined as the occurrence of any treatment-emergent adverse event occurring up to and including Study Day 7 for Part A Cohort 1 or Day 21 for Part A Cohort 2 and Part B. The following criteria defined DLTs: Grade (G) 4 thrombocytopenia; G4 neutropenia (despite optimal supportive care in Part B) lasting \>1 week; febrile neutropenia (only if considered clinically significant in Part B); G4 toxicity; G3 laboratory abnormality lasting \>1 week: G3 toxicity excluding nausea or vomiting controlled within 72 hours, rash in the absence of desquamation, no mucosal involvement, does not require systemic steroids, and resolves to G1 by the next scheduled dose of pembrolizumab or 14 days; G2 or higher episcleritis, uveitis, or iritis; unable to receive 75% of epacadostat or 1 dose of pembrolizumab during the DLT observation period because of toxicity, even if the toxicity does not meet DLT criteria; or \>2 week delay in initiating Cycle 2 due to toxicity.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=3 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=3 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=3 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
n=7 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 39.7 monthsPopulation: All participants who received ≥1 dose of study treatment.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experienced an AE was reported for each arm.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=3 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=3 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=3 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
n=7 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced At Least One Adverse Event (AE)
|
2 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 38.5 monthsPopulation: All participants who received ≥1 dose of study treatment.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who discontinued due to an AE was reported for each arm.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=3 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=3 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=3 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
n=7 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to An Adverse Event (AE)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdosePopulation: The analysis population consisted of all participants in Part A that contributed blood samples for analysis of Cmax. Per protocol, Cmax was only measured on Day 5 for Part A Cohort 2.
Cmax was the maximum observed concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Cmax for Cohort 1 was measured on Days 1, 5, and 12 and Cmax for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Cmax is presented as a geometric mean with a percent geometric coefficient of variation.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=3 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=3 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=3 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of Epacadostat in Part A
Day 1
|
1060 nM
Geometric Coefficient of Variation 19.7
|
—
|
—
|
327 nM
Geometric Coefficient of Variation 15.9
|
—
|
—
|
—
|
|
Maximum Concentration (Cmax) of Epacadostat in Part A
Day 5
|
1100 nM
Geometric Coefficient of Variation 36.8
|
371 nM
Geometric Coefficient of Variation 10.7
|
852 nM
Geometric Coefficient of Variation 74.0
|
269 nM
Geometric Coefficient of Variation 19.3
|
—
|
—
|
—
|
|
Maximum Concentration (Cmax) of Epacadostat in Part A
Day 12
|
1200 nM
Geometric Coefficient of Variation 27.0
|
—
|
—
|
294 nM
Geometric Coefficient of Variation 43.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdosePopulation: The analysis population consisted of all participants in Part A that contributed blood samples for analysis of Tmax. Per protocol, Tmax was only measured on Day 5 for Part A Cohort 2.
Tmax was the time required to reach the maximum concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Tmax for Cohort 1 was measured on Days 1, 5, and 12 and Tmax for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Tmax is presented as a Median with a full range.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=3 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=3 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=3 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of Epacadostat in Part A
Day 1
|
2.00 hours
Interval 2.0 to 2.0
|
—
|
—
|
2.00 hours
Interval 2.0 to 2.0
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax) of Epacadostat in Part A
Day 5
|
2.00 hours
Interval 2.0 to 4.0
|
2.00 hours
Interval 2.0 to 2.0
|
2.00 hours
Interval 1.0 to 4.0
|
2.00 hours
Interval 2.0 to 2.0
|
—
|
—
|
—
|
|
Time to Maximum Concentration (Tmax) of Epacadostat in Part A
Day 12
|
2.00 hours
Interval 2.0 to 4.0
|
—
|
—
|
2.00 hours
Interval 2.0 to 2.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdosePopulation: The analysis population consisted of all participants in Part A that contributed blood samples for analysis of AUC 0-t. Per protocol, AUC0-t was only measured on Day 5 for Part A Cohort 2.
AUC0-t was defined as the AUC from zero to the time of the last measurable concentration of epacadostat in plasma for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, AUC0-t for Cohort 1 was measured on Days 1, 5, and 12 and AUC0-t for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). AUC0-t is presented as a geometric mean with a percent geometric coefficient of variation.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=3 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=3 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=3 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) of Epacadostat in Part A
Day 5
|
4670 nM•hour
Geometric Coefficient of Variation 22.7
|
1260 nM•hour
Geometric Coefficient of Variation 8.8
|
3950 nM•hour
Geometric Coefficient of Variation 38.8
|
1060 nM•hour
Geometric Coefficient of Variation 24.0
|
—
|
—
|
—
|
|
Area Under the Concentration-Time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) of Epacadostat in Part A
Day 12
|
4710 nM•hour
Geometric Coefficient of Variation 17.9
|
—
|
—
|
1020 nM•hour
Geometric Coefficient of Variation 27.3
|
—
|
—
|
—
|
|
Area Under the Concentration-Time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) of Epacadostat in Part A
Day 1
|
4250 nM•hour
Geometric Coefficient of Variation 7.1
|
—
|
—
|
855 nM•hour
Geometric Coefficient of Variation 13.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predosePopulation: The analysis population consisted of all participants in Part A that contributed blood samples for analysis of Ctrough. Per protocol, Ctrough was only measured on Day 5 for Part A Cohort 2.
Ctrough was the lowest concentration of epacadostat in plasma just before the next dose for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, Ctrough for Cohort 1 was measured on Days 1, 5, and 12 and Ctrough for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). Ctrough is presented as a geometric mean with a percent geometric coefficient of variation.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=3 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=3 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=3 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Epacadostat in Part A
Day 5
|
87.7 nM
Geometric Coefficient of Variation 21.7
|
NA nM
Geometric Coefficient of Variation NA
Ctrough less than the limitation of quantification of the assay (20 nM).
|
106.0 nM
Geometric Coefficient of Variation 64.1
|
NA nM
Geometric Coefficient of Variation NA
Ctrough less than the limitation of quantification of the assay (20 nM).
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of Epacadostat in Part A
Day 12
|
95.4 nM
Geometric Coefficient of Variation 31.8
|
—
|
—
|
NA nM
Geometric Coefficient of Variation NA
Ctrough less than the limitation of quantification of the assay (20 nM).
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of Epacadostat in Part A
Day 1
|
NA nM
Geometric Coefficient of Variation NA
Ctrough not calculated predose Cycle 1 Day 1 because it preceded exposure.
|
—
|
—
|
NA nM
Geometric Coefficient of Variation NA
Ctrough not calculated predose Cycle 1 Day 1 because it preceded exposure.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (28-day cycle): Days 1, 5, and 12 at predose and 0.5, 1, 2, 4, 6, 8 and 10 hours postdosePopulation: The analysis population consisted of all participants in Part A that contributed blood samples for analysis of t1/2. Per protocol, t1/2 was only measured on Day 5 for Part A Cohort 2.
t1/2 was the time required to divide the epacadostat concentration by two after reaching pseudo-equilibrium. Plasma t1/2 was measured for epacadostat administered alone (Cohort 1) and epacadostat administered with pembrolizumab (Cohort 2). Per protocol, t1/2 for Cohort 1 was measured on Days 1, 5, and 12 and t1/2 for Cohort 2 was measured on Day 5 only. Blood samples were collected pre-dose and post-dose at multiple time points up to 12 days during Cycle 1 (28-day cycle). t1/2 is presented as a geometric mean with a percent geometric coefficient of variation.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=3 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=3 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=3 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of Epacadostat in Part A
Day 1
|
2.55 hours
Geometric Coefficient of Variation 40.9
|
—
|
—
|
3.94 hours
Geometric Coefficient of Variation NA
Percent geometric coefficient of variation could not be calculated on data from 2 participants.
|
—
|
—
|
—
|
|
Terminal Half-Life (t1/2) of Epacadostat in Part A
Day 5
|
2.82 hours
Geometric Coefficient of Variation 45.1
|
2.62 hours
Geometric Coefficient of Variation 9.7
|
3.77 hours
Geometric Coefficient of Variation 21.9
|
3.01 hours
Geometric Coefficient of Variation 70.6
|
—
|
—
|
—
|
|
Terminal Half-Life (t1/2) of Epacadostat in Part A
Day 12
|
2.43 hours
Geometric Coefficient of Variation 16.1
|
—
|
—
|
4.27 hours
Geometric Coefficient of Variation 86.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1): Day 1 predose and postdose within 30 minutes after the end of pembrolizumab infusionPopulation: The analysis population consisted of all participants in Part A that contributed blood samples for analysis of Cmax. Per protocol, the Cmax of pembrolizumab for Part A was planned to be measured using data combined for Cohort 1 and Cohort 2 for the 200 mg pembrolizumab dose regimen irrespective of epacadostat dose received.
Cmax was the maximum observed concentration of pembrolizumab in serum for participants that received either dose regimen in Part A for Cohort 1 combined, Cohort 2 combined, and Cohorts 1+2 combined. Per protocol, the analysis for the Cmax of pembrolizumab was performed in Cycle 1 only. Blood samples were collected predose and postdose within 30 minutes post pembrolizumab infusion during Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cmax is presented as a geometric mean with a percent geometric coefficient of variation.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=9 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=15 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=6 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of Pembrolizumab in Part A Cycle 1
|
73.8 µg/mL
Geometric Coefficient of Variation 25.7
|
76.2 µg/mL
Geometric Coefficient of Variation 21.1
|
—
|
80.0 µg/mL
Geometric Coefficient of Variation 12.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1): Day 1 predose and postdose within 30 minutes after the end of pembrolizumab infusionPopulation: The analysis population consisted of all participants in Part B that contributed blood samples for analysis of Cmax.
Cmax was the maximum observed concentration of pembrolizumab in serum for participants that received either dose regimen in Part B for Cohort 1, Cohort 2, Cohort 3, and Cohorts 1+2+ 3 combined. Per protocol, the analysis for the Cmax of pembrolizumab was performed in Cycle 1 only. Blood samples were collected predose and postdose within 30 minutes post pembrolizumab infusion during Cycle 1 (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cmax is presented as a geometric mean with a percent geometric coefficient of variation.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=6 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=19 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=7 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of Pembrolizumab in Part B Cycle 1
|
64.3 µg/mL
Geometric Coefficient of Variation 32.1
|
65.3 µg/mL
Geometric Coefficient of Variation 22.4
|
68.0 µg/mL
Geometric Coefficient of Variation 26.0
|
73.8 µg/mL
Geometric Coefficient of Variation 25.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose prior to the Cycles 1, 2, 4, 6, and 8 infusionPopulation: The analysis population consisted of all participants in Part A that contributed blood samples for analysis of Ctrough. Per protocol, the Ctrough of pembrolizumab for Part A was planned to be measured using data combined for Cohort 1 and Cohort 2 for the 200 mg pembrolizumab dose regimen irrespective of epacadostat dose received.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose for participants that received either dose regimen in Part A for Cohort 1 combined, Cohort 2 combined, and Cohorts 1+2 combined. Per protocol, blood sampling for Ctrough was taken at predose prior to the Cycle 1, 2, 4, 6, and 8 infusion. Cycle 1 length was 28 days (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cycle 2, 4, 6, and 8 length was 21 days. Ctrough is presented as a geometric mean with a percent geometric coefficient of variation.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=9 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=15 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=6 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab in Part A Cycles 1, 2, 4, 6, and 8
Cycle 1
|
NA µg/mL
Geometric Coefficient of Variation NA
Ctrough less than the limitation of quantification of the assay (20 nM)
|
NA µg/mL
Geometric Coefficient of Variation NA
Ctrough less than the limitation of quantification of the assay (20 nM)
|
—
|
NA µg/mL
Geometric Coefficient of Variation NA
Ctrough less than the limitation of quantification of the assay (20 nM)
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of Pembrolizumab in Part A Cycles 1, 2, 4, 6, and 8
Cycle 2
|
17.9 µg/mL
Geometric Coefficient of Variation 33.5
|
17.6 µg/mL
Geometric Coefficient of Variation 29.6
|
—
|
17.3 µg/mL
Geometric Coefficient of Variation 26.6
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of Pembrolizumab in Part A Cycles 1, 2, 4, 6, and 8
Cycle 4
|
41.8 µg/mL
Geometric Coefficient of Variation 21.1
|
35.0 µg/mL
Geometric Coefficient of Variation 36.0
|
—
|
24.5 µg/mL
Geometric Coefficient of Variation 31.3
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of Pembrolizumab in Part A Cycles 1, 2, 4, 6, and 8
Cycle 6
|
51.0 µg/mL
Geometric Coefficient of Variation 17.4
|
39.8 µg/mL
Geometric Coefficient of Variation 37.5
|
—
|
28.5 µg/mL
Geometric Coefficient of Variation 25.3
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of Pembrolizumab in Part A Cycles 1, 2, 4, 6, and 8
Cycle 8
|
47.9 µg/mL
Geometric Coefficient of Variation 13.9
|
45.2 µg/mL
Geometric Coefficient of Variation 16.1
|
—
|
38.2 µg/mL
Geometric Coefficient of Variation NA
Percent geometric coefficient of variation could not be calculated on data from 1 participant.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose prior to the Cycles 1, 2, 4, 6, and 8 infusionPopulation: The analysis population consisted of all participants in Part B that contributed blood samples for analysis of Ctrough.
Ctrough was the lowest concentration of pembrolizumab in serum just before the next dose for participants that received either dose regimen in Part B for Cohort 1, Cohort 2, Cohort 3, and Cohorts 1+2+3 combined. Per protocol, blood sampling for Ctrough was taken at pre-dose prior to the Cycle 1, 2, 4, 6, and 8 infusion. Cycle 1 length was 28 days (21-day pembrolizumab treatment cycle starting at Day 8 of Cycle 1). Cycle 2, 4, 6, and 8 length was 21 days. Ctrough is presented as a geometric mean with a percent geometric coefficient of variation.
Outcome measures
| Measure |
Part A Cohort 1: Epacadostat 100 mg
n=6 Participants
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=6 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=19 Participants
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 25 mg
n=7 Participants
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Pembrolizumab in Part B Cycles 1, 2, 4, 6, and 8
Cycle 1
|
NA µg/mL
Geometric Coefficient of Variation NA
Ctrough less than the limitation of quantification of the assay (20 nM)
|
NA µg/mL
Geometric Coefficient of Variation NA
Ctrough less than the limitation of quantification of the assay (20 nM)
|
NA µg/mL
Geometric Coefficient of Variation NA
Ctrough less than the limitation of quantification of the assay (20 nM)
|
NA µg/mL
Geometric Coefficient of Variation NA
Ctrough less than the limitation of quantification of the assay (20 nM)
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of Pembrolizumab in Part B Cycles 1, 2, 4, 6, and 8
Cycle 2
|
17.4 µg/mL
Geometric Coefficient of Variation 36.6
|
8.69 µg/mL
Geometric Coefficient of Variation 122
|
13.3 µg/mL
Geometric Coefficient of Variation 73.9
|
16.6 µg/mL
Geometric Coefficient of Variation 27.6
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of Pembrolizumab in Part B Cycles 1, 2, 4, 6, and 8
Cycle 4
|
28.1 µg/mL
Geometric Coefficient of Variation NA
Percent geometric coefficient of variation could not be calculated on data from 2 participants.
|
25.4 µg/mL
Geometric Coefficient of Variation 25.7
|
31.5 µg/mL
Geometric Coefficient of Variation 28.5
|
37.8 µg/mL
Geometric Coefficient of Variation 20.2
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of Pembrolizumab in Part B Cycles 1, 2, 4, 6, and 8
Cycle 6
|
40.5 µg/mL
Geometric Coefficient of Variation NA
Percent geometric coefficient of variation could not be calculated on data from 2 participants.
|
21.5 µg/mL
Geometric Coefficient of Variation 130
|
38.6 µg/mL
Geometric Coefficient of Variation 73.5
|
53.8 µg/mL
Geometric Coefficient of Variation 29.5
|
—
|
—
|
—
|
|
Trough Concentration (Ctrough) of Pembrolizumab in Part B Cycles 1, 2, 4, 6, and 8
Cycle 8
|
52.7 µg/mL
Geometric Coefficient of Variation NA
Percent geometric coefficient of variation could not be calculated on data from 2 participants.
|
34.5 µg/mL
Geometric Coefficient of Variation 42.9
|
50.3 µg/mL
Geometric Coefficient of Variation 39.6
|
65.4 µg/mL
Geometric Coefficient of Variation 18.6
|
—
|
—
|
—
|
Adverse Events
Part A Cohort 1: Epacadostat 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Part A Cohort 1: Epacadostat 100 mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 3 deaths
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
Serious events: 1 serious events
Other events: 6 other events
Deaths: 3 deaths
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part A Cohort 1: Epacadostat 25 mg
n=3 participants at risk
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 100 mg
n=3 participants at risk
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=3 participants at risk
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=6 participants at risk
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
n=7 participants at risk
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
n=6 participants at risk
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
n=6 participants at risk
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
Other adverse events
| Measure |
Part A Cohort 1: Epacadostat 25 mg
n=3 participants at risk
Participants received 25 mg of epacadostat orally twice daily (BID) alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time intravenous (IV) infusion of 200 mg pembrolizumab while continuing to receive 25 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 1: Epacadostat 100 mg
n=3 participants at risk
Participants received 100 mg of epacadostat orally BID alone on Days 1-5 of Cycle 1 (28-day cycle) with a washout on Days 6 and 7. On Day 8 participants received a one-time IV infusion of 200 mg pembrolizumab while continuing to receive 100 mg of epacadostat BID on Days 8-28. For each 21-day cycle thereafter, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 25 mg+Pembrolizumab
n=3 participants at risk
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 25 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part A Cohort 2: Epacadostat 100 mg+Pembrolizumab
n=6 participants at risk
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and received 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years).
|
Part B Cohort 1: Pembrolizumab+Cisplatin+Pemetrexed
n=7 participants at risk
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of 75 mg/m\^2 cisplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 2: Pembrolizumab+Carboplatin+Pemetrexed
n=6 participants at risk
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of Area Under the Curve (AUC) 5 carboplatin and 500 mg/m\^2 pemetrexed on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
Part B Cohort 3: Pembrolizumab+Carboplatin+Paclitaxel
n=6 participants at risk
For each 21-day cycle, participants received a one-time IV infusion of 200 mg pembrolizumab on Day 1 and 100 mg of epacadostat orally BID on Days 1-21 for up to 35 cycles (approximately 2 years). For the first 4 cycles, participants also received a one-time IV infusion of AUC 6 carboplatin and 200 mg/m\^2 paclitaxel on Day 1. Treatment with epacadostat was stopped with protocol amendment 02.
|
|---|---|---|---|---|---|---|---|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
50.0%
3/6 • Number of events 5 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
66.7%
2/3 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
85.7%
6/7 • Number of events 7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
83.3%
5/6 • Number of events 5 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Anal erosion
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
66.7%
2/3 • Number of events 5 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
57.1%
4/7 • Number of events 8 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
83.3%
5/6 • Number of events 8 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
57.1%
4/7 • Number of events 5 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
General disorders
Malaise
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
28.6%
2/7 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
General disorders
Oedema
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
28.6%
2/7 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
57.1%
4/7 • Number of events 4 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Infections and infestations
Cystitis
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
42.9%
3/7 • Number of events 3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
57.1%
4/7 • Number of events 9 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
50.0%
3/6 • Number of events 6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
42.9%
3/7 • Number of events 4 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
50.0%
3/6 • Number of events 5 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 4 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
50.0%
3/6 • Number of events 8 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Electrocardiogram QT prolonged
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 9 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 4 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 4 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
50.0%
3/6 • Number of events 3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 9 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 5 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
28.6%
2/7 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
50.0%
3/6 • Number of events 6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Nervous system disorders
Vagus nerve disorder
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Renal and urinary disorders
Pollakiuria
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
66.7%
4/6 • Number of events 4 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • Number of events 4 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
66.7%
2/3 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
2/6 • Number of events 3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
28.6%
2/7 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
33.3%
1/3 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Vascular disorders
Vascular pain
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/7 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
16.7%
1/6 • Number of events 2 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/3 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
14.3%
1/7 • Number of events 1 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
0.00%
0/6 • Up to approximately 39.7 months
The analysis population for adverse events (AEs) and all-cause mortality consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms neoplasm progression, malignant neoplasm progression, and disease progression not related to study treatment and/or did not result in death/hospitalization are excluded.
|
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 The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER