Trial Outcomes & Findings for Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 (NCT NCT03307785)
NCT ID: NCT03307785
Last Updated: 2025-11-25
Results Overview
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
21 days
Results posted on
2025-11-25
Participant Flow
A total of 60 participants were enrolled in the study and 2 participants who originally signed inform consent form (ICF) withdrew their consent shortly from study before treatment assignment and a total of 58 participants were part of the study.
The study consisted of two phases - Main Study Phase and Post Analysis Continued Treatment (PACT) Phase. Main Study Phase was planned to be a nine-part study with Parts A to I. However, Parts G, H and I were not initiated due to business strategic reason. In PACT phase those participants benefiting from treatment continued to receive study drug until discontinuation or withdrawal from study.
Participant milestones
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
|
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
|
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
|
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (every week \[Q1W\]) of every 3 week cycle for 4 to 6 cycles.
|
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
|
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
|
PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
|
PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Main Study: Part A: Up to 28.5 Months
STARTED
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16
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6
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Main Study: Part A: Up to 28.5 Months
COMPLETED
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0
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0
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0
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Main Study: Part A: Up to 28.5 Months
NOT COMPLETED
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16
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6
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MainStudy: PartB: Up to Approx.66months
STARTED
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14
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MainStudy: PartB: Up to Approx.66months
COMPLETED
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0
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0
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MainStudy: PartB: Up to Approx.66months
NOT COMPLETED
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14
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MainStudy: PartC:Up to Approx.60months
STARTED
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6
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7
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MainStudy: PartC:Up to Approx.60months
COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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MainStudy: PartC:Up to Approx.60months
NOT COMPLETED
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0
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0
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0
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6
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7
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0
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0
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0
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0
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0
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MainStudy:PartD:Up to Approx. 62.5months
STARTED
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0
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0
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0
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6
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0
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0
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0
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0
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MainStudy:PartD:Up to Approx. 62.5months
COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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MainStudy:PartD:Up to Approx. 62.5months
NOT COMPLETED
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0
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0
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0
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0
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0
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6
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0
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0
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0
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0
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Main Study: Part E: Up to 4.4 Months
STARTED
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2
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Main Study: Part E: Up to 4.4 Months
COMPLETED
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0
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Main Study: Part E: Up to 4.4 Months
NOT COMPLETED
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0
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0
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2
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0
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Main Study: Part F: Up to 3.5 Months
STARTED
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0
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1
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0
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0
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Main Study: Part F: Up to 3.5 Months
COMPLETED
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0
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0
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0
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Main Study: Part F: Up to 3.5 Months
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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1
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0
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0
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Main Study: Part G: Up to 24 Months
STARTED
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0
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0
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Main Study: Part G: Up to 24 Months
COMPLETED
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0
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0
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Main Study: Part G: Up to 24 Months
NOT COMPLETED
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0
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0
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0
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Main Study: Part H: Up to 24 Months
STARTED
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Main Study: Part H: Up to 24 Months
COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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Main Study: Part H: Up to 24 Months
NOT COMPLETED
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Main Study: Part I: Up to 24 Months
STARTED
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Main Study: Part I: Up to 24 Months
COMPLETED
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0
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Main Study: Part I: Up to 24 Months
NOT COMPLETED
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PACT Phase: Up to 19 Months
STARTED
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2
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1
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PACT Phase: Up to 19 Months
COMPLETED
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0
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2
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PACT Phase: Up to 19 Months
NOT COMPLETED
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0
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0
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1
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Reasons for withdrawal
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
|
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
|
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
|
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (every week \[Q1W\]) of every 3 week cycle for 4 to 6 cycles.
|
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
|
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
|
PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
|
PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Main Study: Part A: Up to 28.5 Months
Disease progression
|
2
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
|
Main Study: Part A: Up to 28.5 Months
Withdrawal by Subject
|
7
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study: Part A: Up to 28.5 Months
Death
|
4
|
4
|
0
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0
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0
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0
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0
|
0
|
0
|
0
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0
|
0
|
0
|
|
Main Study: Part A: Up to 28.5 Months
Physician Decision
|
3
|
1
|
0
|
0
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0
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0
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0
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0
|
0
|
0
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0
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0
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0
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|
MainStudy: PartB: Up to Approx.66months
Disease progression
|
0
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0
|
2
|
0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
|
MainStudy: PartB: Up to Approx.66months
Death
|
0
|
0
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy: PartB: Up to Approx.66months
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy: PartB: Up to Approx.66months
Transitioned to PACT phase
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy: PartB: Up to Approx.66months
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy: PartC:Up to Approx.60months
Physician Decision
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy: PartC:Up to Approx.60months
Death
|
0
|
0
|
0
|
2
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy: PartC:Up to Approx.60months
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy: PartC:Up to Approx.60months
Went on Another Clinical Trial
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy:PartD:Up to Approx. 62.5months
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy:PartD:Up to Approx. 62.5months
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy:PartD:Up to Approx. 62.5months
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy:PartD:Up to Approx. 62.5months
Transitioned to PACT phase
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
MainStudy:PartD:Up to Approx. 62.5months
Completed EOT and Began New Study
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study: Part E: Up to 4.4 Months
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study: Part E: Up to 4.4 Months
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study: Part F: Up to 3.5 Months
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
PACT Phase: Up to 19 Months
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042
Baseline characteristics by cohort
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
n=14 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
|
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
n=2 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
|
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
n=1 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
|
Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (every week \[Q1W\]) of every 3 week cycle for 4 to 6 cycles.
|
Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
|
Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel
Participants were planned to receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle was of 21 days).
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-64 years
|
8 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
4 Participants
n=17 Participants
|
6 Participants
n=16 Participants
|
2 Participants
n=82 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
30 Participants
n=6 Participants
|
|
Age, Customized
65-74 years
|
6 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
2 Participants
n=17 Participants
|
1 Participants
n=16 Participants
|
3 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
17 Participants
n=6 Participants
|
|
Age, Customized
>=75 years
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
8 Participants
n=9 Participants
|
4 Participants
n=17 Participants
|
7 Participants
n=16 Participants
|
5 Participants
n=82 Participants
|
0 Participants
n=13 Participants
|
NA Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
NA Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=82 Participants
|
2 Participants
n=13 Participants
|
NA Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
NA Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=16 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=13 Participants
|
NA Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
NA Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
13 Participants
n=9 Participants
|
6 Participants
n=17 Participants
|
5 Participants
n=16 Participants
|
6 Participants
n=82 Participants
|
1 Participants
n=13 Participants
|
NA Participants
n=335 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
NA Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Safety Population consisted of all participants who received any amount of study treatment.
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Number of Participants With Dose-limiting Toxicity (DLT)
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Safety Population.
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=14 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Number of Participants With DLT
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Safety Population.
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Number of Participants With DLT
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Safety Population.
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Number of Participants With DLT
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Safety Population.
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Number of Participants With DLT
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Safety Population.
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Number of Participants With DLT
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Safety Population. Data was not collected as no participants were enrolled in Part G.
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 21 daysPopulation: Safety Population. Data was not collected as no participants were enrolled in Part H.
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 21 daysPopulation: Safety Population. Data was not collected as no participants were enrolled in Part I.
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 28.5 monthsPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)
Non-serious TEAEs
|
16 Participants
|
6 Participants
|
|
Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)
STEAEs
|
11 Participants
|
4 Participants
|
|
Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)
AESIs
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 28.5 monthsPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=14 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
Non-Serious TEAEs
|
14 Participants
|
—
|
|
Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
STEAEs
|
9 Participants
|
—
|
|
Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
AESIs
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 22.5 monthsPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
Non-serious TEAEs
|
5 Participants
|
7 Participants
|
|
Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
STEAEs
|
3 Participants
|
3 Participants
|
|
Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
AESIs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 9.5 monthsPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
Non-serious TEAEs
|
6 Participants
|
—
|
|
Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
STEAEs
|
3 Participants
|
—
|
|
Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
AESIs
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 4.4 monthsPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
Non-serious TEAEs
|
2 Participants
|
—
|
|
Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
STEAEs
|
2 Participants
|
—
|
|
Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
AESIs
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 3.5 monthsPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
Non-serious TEAEs
|
1 Participants
|
—
|
|
Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
STEAEs
|
0 Participants
|
—
|
|
Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
AESIs
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part G.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part H.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part I.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28.5 monthsPopulation: Safety Population.
Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Objective Response Rate
|
25.0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 28.5 monthsPopulation: Safety Population.
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=14 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Objective Response Rate
|
42.9 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 22.5 monthsPopulation: Safety Population.
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Objective Response Rate
|
50.0 Percentage of participants
|
14.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 9.5 monthsPopulation: Safety Population.
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Objective Response Rate
|
50.0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 4.4 monthsPopulation: Safety Population.
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Objective Response Rate
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 3.5 monthsPopulation: Safety Population.
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Objective Response Rate
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part G.
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part H.
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part I.
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28.5 monthsPopulation: Safety Population.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Duration of Response
|
7.59 Months
Interval 5.78 to 10.94
|
NA Months
Duration of response could not be calculated as no participants had a confirmed CR or PR in TSR-042 and niraparib 300 mg QD arm.
|
SECONDARY outcome
Timeframe: Up to approximately 66 monthsPopulation: Safety Population.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=14 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Duration of Response
|
NA Months
Median and full range were not calculable due to more than 50% censored participants in this treatment group.
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 60 monthsPopulation: Safety Population.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Duration of Response
|
NA Months
Median and full range were not calculable due to more than 50% censored participants in this treatment group.
|
NA Months
Median and full range were not calculable due to more than 50% censored participants in this treatment group.
|
SECONDARY outcome
Timeframe: Up to approximately 62.5 monthsPopulation: Safety Population.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Duration of Response
|
NA Months
Median and full range were not calculable due to more than 50% censored participants in this treatment group.
|
—
|
SECONDARY outcome
Timeframe: Up to 4.4 monthsPopulation: Safety Population.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Duration of Response
|
NA Months
Duration of response could not be calculated as no participants had a confirmed CR or PR.
|
—
|
SECONDARY outcome
Timeframe: Up to 3.5 monthsPopulation: Safety Population.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Duration of Response
|
NA Months
Median and full range could not be calculated as there were no confirmed CR or PR.
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part G.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part H.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part I.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28.5 monthsPopulation: Safety Population.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Disease Control Rate
|
43.8 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 28.5 monthsPopulation: Safety Population.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=14 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Disease Control Rate
|
57.1 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 22.5 monthsPopulation: Safety Population.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Disease Control Rate
|
83.3 Percentage of participants
|
85.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 9.5 monthsPopulation: Safety Population.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Disease Control Rate
|
83.3 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 4.4 monthsPopulation: Safety Population.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Disease Control Rate
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 3.5 monthsPopulation: Safety Population.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Disease Control Rate
|
100 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part G.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part H.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part I.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28.5 monthsPopulation: Safety Population.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Progression-free Survival
|
6.2 Months
Interval 2.2 to 9.9
|
2.8 Months
Interval 2.3 to 4.7
|
SECONDARY outcome
Timeframe: Up to 28.5 monthsPopulation: Safety Population.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=14 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Progression-free Survival
|
17.6 Months
Interval 3.9 to
\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
|
—
|
SECONDARY outcome
Timeframe: Up to 22.5 monthsPopulation: Safety Population.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Progression-free Survival
|
NA Months
Interval 8.5 to
\<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived.
|
9.1 Months
Interval 8.0 to 11.1
|
SECONDARY outcome
Timeframe: Up to 9.5 monthsPopulation: Safety Population.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Progression-free Survival
|
7.6 Months
Interval 7.4 to
\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.
|
—
|
SECONDARY outcome
Timeframe: Up to 4.4 monthsPopulation: Safety Population.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Progression-free Survival
|
NA Months
Median and Inter Quartile range could not be estimated due to the low number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Up to 3.5 monthsPopulation: Safety Population.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Progression-free Survival
|
NA Months
Median and Inter Quartile range could not be estimated due to the low number of participant with event.
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part G.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part H.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population. Data was not collected as no participants were enrolled in Part I.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 28.5 monthsPopulation: Anti-drug Antibody Population.
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Number of Participants With Positive Anti-TSR-042 Antibodies
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 28.5 monthsPopulation: Anti-drug Antibody Population.
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=14 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Number of Participants With Positive Anti-TSR-042 Antibodies
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 22.5 monthsPopulation: Anti-drug Antibody Population.
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Number of Participants With Positive Anti-TSR-042 Antibodies
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 9.5 monthsPopulation: Anti-drug Antibody Population.
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Number of Participants With Positive Anti-TSR-042 Antibodies
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 4.4 monthsPopulation: Anti-drug Antibody Population.
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Number of Participants With Positive Anti-TSR-042 Antibodies
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 3.5 monthsPopulation: Anti-drug Antibody Population.
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Number of Participants With Positive Anti-TSR-042 Antibodies
|
NA Participants
Data could not be calculated due to insufficient participant with data.
|
—
|
SECONDARY outcome
Timeframe: Up to 3.5 monthsPopulation: Anti-drug Antibody Population.
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Number of Participants With Positive Anti-TSR-022 Antibodies
|
NA Participants
Data could not be calculated due to insufficient participant with data.
|
—
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part G.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part H.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Anti-drug Antibody Population. Data was not collected as no participants were enrolled in Part I.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=15 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib
Cycle 1, n=15,6
|
6.0430 Hours*microgram per milliliter
Standard Deviation 3.43261
|
7.8341 Hours*microgram per milliliter
Standard Deviation 4.76380
|
|
Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib
Cycle 2, n=10,3
|
14.9172 Hours*microgram per milliliter
Standard Deviation 9.82689
|
29.3024 Hours*microgram per milliliter
Standard Deviation 2.15129
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: AUC(0-t) of TSR-042
Cycle 5, n=8,1
|
137108.2574 Hours*microgram per milliliter
Standard Deviation 41494.15474
|
141328.9288 Hours*microgram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Part A: AUC(0-t) of TSR-042
Cycle 11, n=5,0
|
139591.8834 Hours*microgram per milliliter
Standard Deviation 53844.12650
|
—
|
|
Part A: AUC(0-t) of TSR-042
Cycle 4, n=9,4
|
55408.3992 Hours*microgram per milliliter
Standard Deviation 21631.17124
|
29311.8182 Hours*microgram per milliliter
Standard Deviation 16546.73177
|
|
Part A: AUC(0-t) of TSR-042
Cycle 1, n=16,6
|
26827.7703 Hours*microgram per milliliter
Standard Deviation 9811.74994
|
29420.8347 Hours*microgram per milliliter
Standard Deviation 9262.18751
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=14 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: AUC0-t of TSR-042
Cycle 1, n=14
|
28097.9846 Hours*microgram per milliliter
Standard Deviation 8440.50578
|
—
|
|
Part B: AUC0-t of TSR-042
Cycle 4, n=10
|
54730.0053 Hours*microgram per milliliter
Standard Deviation 15857.69305
|
—
|
|
Part B: AUC0-t of TSR-042
Cycle 5, n=9
|
124309.5455 Hours*microgram per milliliter
Standard Deviation 56505.10671
|
—
|
|
Part B: AUC0-t of TSR-042
Cycle 11, n=6
|
117030.4081 Hours*microgram per milliliter
Standard Deviation 33852.45635
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: AUC0-t of Niraparib
Cycle 1, n=6,7
|
3.4513 Hours*microgram per milliliter
Standard Deviation 1.23048
|
11.3601 Hours*microgram per milliliter
Standard Deviation 5.53524
|
|
Part C: AUC0-t of Niraparib
Cycle 2, n=4,4
|
14.7473 Hours*microgram per milliliter
Standard Deviation 8.11715
|
24.9691 Hours*microgram per milliliter
Standard Deviation 17.50367
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: AUC0-t of TSR-042
Cycle 1, n=6,7
|
29830.6542 Hours*microgram per milliliter
Standard Deviation 8143.36941
|
26311.1789 Hours*microgram per milliliter
Standard Deviation 4416.61957
|
|
Part C: AUC0-t of TSR-042
Cycle 4, n=5,7
|
54268.1379 Hours*microgram per milliliter
Standard Deviation 14777.09545
|
49198.8237 Hours*microgram per milliliter
Standard Deviation 12507.66126
|
|
Part C: AUC0-t of TSR-042
Cycle 5, n=5,6
|
137777.3188 Hours*microgram per milliliter
Standard Deviation 45794.21973
|
131281.9046 Hours*microgram per milliliter
Standard Deviation 36835.39730
|
|
Part C: AUC0-t of TSR-042
Cycle 11, n=4,2
|
143070.3093 Hours*microgram per milliliter
Standard Deviation 74219.00272
|
119161.8795 Hours*microgram per milliliter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: AUC0-t of TSR-042
Cycle 1, n=6
|
32819.5401 Hours*microgram per milliliter
Standard Deviation 9182.44511
|
—
|
|
Part D: AUC0-t of TSR-042
Cycle 4, n=5
|
52409.0255 Hours*microgram per milliliter
Standard Deviation 11814.13244
|
—
|
|
Part D: AUC0-t of TSR-042
Cycle 5, n=5
|
119847.0999 Hours*microgram per milliliter
Standard Deviation 27279.85524
|
—
|
|
Part D: AUC0-t of TSR-042
Cycle 11, n=4
|
77794.6422 Hours*microgram per milliliter
Standard Deviation 38680.64753
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: AUC0-t of TSR-042
|
NA Hours*microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate AUC0-t.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: AUC0-t of TSR-042
|
NA Hours*microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate AUC0-t.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: AUC0-t of TSR-022
|
NA Hours*microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate AUC0-t.
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: AUC(0-infinity) of TSR-042
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=14 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: AUC(0-infinity) of TSR-042
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: AUC(0-infinity) of Niraparib
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: AUC(0-infinity) of TSR-042
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: AUC(0-infinity) of TSR-042
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
The terminal elimination phase could not be identified from the concentration-time profile over the study period; hence, AUC(0-infinity) could not be estimated.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: AUC(0-infinity) of TSR-042
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
Data was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: AUC(0-infinity) of TSR-042
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
Data was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: AUC(0-infinity) of TSR-022
|
NA Hours*microgram per milliliter
Geometric Coefficient of Variation NA
Data was not collected due to insufficient number of participants with data to calculate AUC(0-infinity).
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=15 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib
|
0.191953 Microgram per milliliter
Standard Deviation 0.1309536
|
0.342333 Microgram per milliliter
Standard Deviation 0.3301392
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=9 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=4 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Ctau of TSR-042
|
33.6000 Microgram per milliliter
Standard Deviation 12.25194
|
29.8000 Microgram per milliliter
Standard Deviation 10.32570
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=9 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Ctau of TSR-042
|
33.9778 Microgram per milliliter
Standard Deviation 9.89846
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Ctau of Niraparib
|
0.161233 Microgram per milliliter
Standard Deviation 0.1072328
|
0.478714 Microgram per milliliter
Standard Deviation 0.4197538
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=4 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=4 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Ctau of TSR-042
|
37.2750 Microgram per milliliter
Standard Deviation 16.78102
|
28.7500 Microgram per milliliter
Standard Deviation 9.47505
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=4 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Ctau of TSR-042
|
36.5250 Microgram per milliliter
Standard Deviation 12.29834
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Ctau of TSR-042
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Ctau.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Ctau of TSR-042
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Ctau.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Ctau of TSR-022
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Ctau.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=15 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Maximum Observed Plasma (Cmax) of Niraparib
|
0.460600 Microgram per milliliter
Standard Deviation 0.2401100
|
0.625667 Microgram per milliliter
Standard Deviation 0.4547692
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Cmax of TSR-042
|
158.6875 Microgram per milliliter
Standard Deviation 27.70251
|
138.9167 Microgram per milliliter
Standard Deviation 37.87930
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=14 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Cmax of TSR-042
|
148.2000 Microgram per milliliter
Standard Deviation 31.27948
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Cmax of Niraparib
|
0.243667 Microgram per milliliter
Standard Deviation 0.0889936
|
0.891571 Microgram per milliliter
Standard Deviation 0.4638897
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Cmax of TSR-042
|
138.6667 Microgram per milliliter
Standard Deviation 24.14677
|
158.4857 Microgram per milliliter
Standard Deviation 48.36788
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Cmax of TSR-042
|
188.5000 Microgram per milliliter
Standard Deviation 36.04858
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Cmax of TSR-042
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Cmax.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Cmax of TSR-042
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Cmax.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Cmax of TSR-022
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Cmax.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=8 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=2 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Clearance After Oral Administration (CL/F) of Niraparib
Cycle 1, n=1,0
|
28.5638 Liter per hour
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
|
Part A: Clearance After Oral Administration (CL/F) of Niraparib
Cycle 2, n=8,2
|
16.6295 Liter per hour
Standard Deviation 8.70836
|
10.2833 Liter per hour
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=8 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=2 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Clearance After Intravenous Administration (CL) of TSR-042
Cycle 4, n=7,2
|
0.0090 Liter per hour
Standard Deviation 0.00220
|
0.0110 Liter per hour
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
|
Part A: Clearance After Intravenous Administration (CL) of TSR-042
Cycle 5, n=8,1
|
0.0081 Liter per hour
Standard Deviation 0.00238
|
0.0071 Liter per hour
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Part A: Clearance After Intravenous Administration (CL) of TSR-042
Cycle 11, n=4,0
|
0.0072 Liter per hour
Standard Deviation 0.00217
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=10 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: CL of TSR-042
Cycle 4, n=10
|
0.0098 Liter per hour
Standard Deviation 0.00292
|
—
|
|
Part B: CL of TSR-042
Cycle 5, n=8
|
0.0082 Liter per hour
Standard Deviation 0.00242
|
—
|
|
Part B: CL of TSR-042
Cycle 11, n=6
|
0.0092 Liter per hour
Standard Deviation 0.00296
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=4 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: CL/F of Niraparib
Cycle 2, n=2,4
|
10.3777 Liter per hour
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
14.4947 Liter per hour
Standard Deviation 8.40967
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: CL of TSR-042
Cycle 4, n=5,5
|
0.0100 Liter per hour
Standard Deviation 0.00441
|
0.0104 Liter per hour
Standard Deviation 0.00268
|
|
Part C: CL of TSR-042
Cycle 5, n=5,6
|
0.0082 Liter per hour
Standard Deviation 0.00370
|
0.0082 Liter per hour
Standard Deviation 0.00273
|
|
Part C: CL of TSR-042
Cycle 11, n=4,2
|
0.0079 Liter per hour
Standard Deviation 0.00391
|
0.0086 Liter per hour
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: CL of TSR-042
Cycle 4, n=5
|
0.0102 Liter per hour
Standard Deviation 0.00210
|
—
|
|
Part D: CL of TSR-042
Cycle 5, n=5
|
0.0087 Liter per hour
Standard Deviation 0.00169
|
—
|
|
Part D: CL of TSR-042
Cycle 11, n=3
|
0.0104 Liter per hour
Standard Deviation 0.00100
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: CL of TSR-042
|
NA Liter per hour
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate CL.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: CL of TSR-042
|
NA Liter per hour
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate CL.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: CL of TSR-022
|
NA Liter per hour
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate CL.
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=8 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=2 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib
Cycle 1, n=1,0
|
380.1478 Liter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
—
|
|
Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib
Cycle 2, n=8,2
|
716.1418 Liter
Standard Deviation 554.80278
|
487.8826 Liter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=8 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=2 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042
Cycle 4, n=5,2
|
5.6925 Liter
Standard Deviation 1.46062
|
10.3984 Liter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
|
Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042
Cycle 5, n=8,1
|
6.8811 Liter
Standard Deviation 1.70545
|
6.3070 Liter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042
Cycle 11, n=4,0
|
7.4795 Liter
Standard Deviation 0.90952
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=10 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Vz of TSR-042
Cycle 4, n=10
|
5.3661 Liter
Standard Deviation 2.01321
|
—
|
|
Part B: Vz of TSR-042
Cycle 5, n=8
|
7.2627 Liter
Standard Deviation 2.43311
|
—
|
|
Part B: Vz of TSR-042
Cycle 11, n=6
|
8.0529 Liter
Standard Deviation 3.64454
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=2 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Vz/F of Niraparib
Cycle 2, n=2,2
|
551.4003 Liter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
559.3634 Liter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Vz of TSR-042
Cycle 4, n=5,5
|
6.6462 Liter
Standard Deviation 2.66825
|
5.8922 Liter
Standard Deviation 2.93257
|
|
Part C: Vz of TSR-042
Cycle 5, n=4,6
|
6.1698 Liter
Standard Deviation 1.73272
|
5.2066 Liter
Standard Deviation 1.07206
|
|
Part C: Vz of TSR-042
Cycle 11, n=4,2
|
9.6347 Liter
Standard Deviation 4.05466
|
8.5098 Liter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
SECONDARY outcome
Timeframe: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Vz of TSR-042
Cycle 4, n=5
|
5.4955 Liter
Standard Deviation 1.89543
|
—
|
|
Part D: Vz of TSR-042
Cycle 5, n=5
|
6.1542 Liter
Standard Deviation 1.57345
|
—
|
|
Part D: Vz of TSR-042
Cycle 11, n=3
|
9.8356 Liter
Standard Deviation 0.99107
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Vz of TSR-042
|
NA Liter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Vz.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Vz of TSR-042
|
NA Liter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Vz.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Vz of TSR-022
|
NA Liter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Vz.
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=8 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=2 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: AUC at Steady State (AUCss) of Niraparib
|
16.3481 Hours*microgram per milliliter
Standard Deviation 10.63803
|
29.4312 Hours*microgram per milliliter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=8 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=3 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: AUCss of TSR-042
Cycle 4, n=7,2
|
58598.5076 Hours*microgram per milliliter
Standard Deviation 15328.61731
|
46122.3924 Hours*microgram per milliliter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
|
Part A: AUCss of TSR-042
Cycle 5, n=8,1
|
135171.2753 Hours*microgram per milliliter
Standard Deviation 43806.32512
|
141306.3782 Hours*microgram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Part A: AUCss of TSR-042
Cycle 11, n=4,0
|
151575.3645 Hours*microgram per milliliter
Standard Deviation 55194.65972
|
—
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=10 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: AUCss of TSR-042
Cycle 4, n=10
|
55073.0926 Hours*microgram per milliliter
Standard Deviation 15304.21896
|
—
|
|
Part B: AUCss of TSR-042
Cycle 5, n=8
|
130694.9752 Hours*microgram per milliliter
Standard Deviation 33923.75772
|
—
|
|
Part B: AUCss of TSR-042
Cycle 11, n=6
|
117033.3612 Hours*microgram per milliliter
Standard Deviation 33727.51653
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=4 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: AUCss of Niraparib
|
21.4926 Hours*microgram per milliliter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
26.5006 Hours*microgram per milliliter
Standard Deviation 14.61077
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: AUCss of TSR-042
Cycle 4, n=5,5
|
55974.4268 Hours*microgram per milliliter
Standard Deviation 16738.05254
|
50924.1510 Hours*microgram per milliliter
Standard Deviation 13339.28085
|
|
Part C: AUCss of TSR-042
Cycle 5, n=5,6
|
137399.5881 Hours*microgram per milliliter
Standard Deviation 45511.62023
|
131288.0291 Hours*microgram per milliliter
Standard Deviation 36816.18787
|
|
Part C: AUCss of TSR-042
Cycle 11, n=4,2
|
147907.5379 Hours*microgram per milliliter
Standard Deviation 60795.87607
|
119189.5905 Hours*microgram per milliliter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: AUCss of TSR-042
Cycle 4, n=5
|
51140.4410 Hours*microgram per milliliter
Standard Deviation 12597.07380
|
—
|
|
Part D: AUCss of TSR-042
Cycle 5, n=5
|
118845.3928 Hours*microgram per milliliter
Standard Deviation 27874.98871
|
—
|
|
Part D: AUCss of TSR-042
Cycle 11, n=3
|
96800.1534 Hours*microgram per milliliter
Standard Deviation 8871.32089
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: AUCss of TSR-042
|
NA Hours*microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate AUCss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: AUCss of TSR-042
|
NA Hours*microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate AUCss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: AUCss of TSR-022
|
NA Hours*microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate AUCss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=11 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Ctau at Steady State (Ctau,ss) of Niraparib
Cycle 2, n=11,6
|
0.507900 Microgram per milliliter
Standard Deviation 0.3937657
|
0.622000 Microgram per milliliter
Standard Deviation 0.4523848
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=8 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=1 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Ctau,ss of TSR-042
Cycle 4, n=8,1
|
77.3625 Microgram per milliliter
Standard Deviation 28.55145
|
63.3000 Microgram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Part A: Ctau,ss of TSR-042
Cycle 5, n=8,1
|
68.5500 Microgram per milliliter
Standard Deviation 34.63879
|
71.2000 Microgram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Part A: Ctau,ss of TSR-042
Cycle 11, n=4,0
|
93.8000 Microgram per milliliter
Standard Deviation 47.28939
|
—
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=9 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Ctau,ss of TSR-042
Cycle 4, n=9
|
67.2444 Microgram per milliliter
Standard Deviation 24.15130
|
—
|
|
Part B: Ctau,ss of TSR-042
Cycle 5, n=8
|
59.3000 Microgram per milliliter
Standard Deviation 16.75913
|
—
|
|
Part B: Ctau,ss of TSR-042
Cycle 11, n=6
|
57.4833 Microgram per milliliter
Standard Deviation 20.98136
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=4 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Ctau,ss of Niraparib
Cycle 2, n=5,4
|
0.484000 Microgram per milliliter
Standard Deviation 0.3511339
|
1.094250 Microgram per milliliter
Standard Deviation 0.7660576
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Ctau,ss of TSR-042
Cycle 4, n=4,6
|
70.4250 Microgram per milliliter
Standard Deviation 34.00896
|
64.2667 Microgram per milliliter
Standard Deviation 23.55315
|
|
Part C: Ctau,ss of TSR-042
Cycle 5, n=5,6
|
82.9800 Microgram per milliliter
Standard Deviation 43.98252
|
53.1500 Microgram per milliliter
Standard Deviation 24.80538
|
|
Part C: Ctau,ss of TSR-042
Cycle 11, n=3,2
|
105.4667 Microgram per milliliter
Standard Deviation 22.28909
|
60.9500 Microgram per milliliter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Ctau,ss of TSR-042
Cycle 4, n=5
|
53.5200 Microgram per milliliter
Standard Deviation 13.87271
|
—
|
|
Part D: Ctau,ss of TSR-042
Cycle 5, n=5
|
48.0800 Microgram per milliliter
Standard Deviation 23.95343
|
—
|
|
Part D: Ctau,ss of TSR-042
Cycle 11, n=3
|
43.3000 Microgram per milliliter
Standard Deviation 4.80729
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Ctau,ss of TSR-042
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Ctau,ss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Ctau,ss of TSR-042
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Ctau,ss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Ctau,ss of TSR-022
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Ctau,ss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=10 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=3 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Cmax at Steady State (Cmax,ss) of Niraparib
Cycle 2, n=10,3
|
0.925900 Microgram per milliliter
Standard Deviation 0.6661597
|
1.706667 Microgram per milliliter
Standard Deviation 0.0838650
|
|
Part A: Cmax at Steady State (Cmax,ss) of Niraparib
Cycle 5, n=7,0
|
0.839071 Microgram per milliliter
Standard Deviation 0.6183628
|
—
|
|
Part A: Cmax at Steady State (Cmax,ss) of Niraparib
Cycle 11, n=2,0
|
0.768000 Microgram per milliliter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
—
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=9 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=4 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Cmax,ss of TSR-042
Cycle 4, n=9,4
|
222.5556 Microgram per milliliter
Standard Deviation 51.37633
|
178.5000 Microgram per milliliter
Standard Deviation 26.18524
|
|
Part A: Cmax,ss of TSR-042
Cycle 5, n=8,1
|
393.8750 Microgram per milliliter
Standard Deviation 100.81729
|
319.0000 Microgram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Part A: Cmax,ss of TSR-042
Cycle 11, n=5,0
|
405.4000 Microgram per milliliter
Standard Deviation 103.69812
|
—
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=10 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Cmax,ss of TSR-042
Cycle 4, n=10
|
225.8000 Microgram per milliliter
Standard Deviation 51.71460
|
—
|
|
Part B: Cmax,ss of TSR-042
Cycle 5, n=9
|
421.1111 Microgram per milliliter
Standard Deviation 114.84603
|
—
|
|
Part B: Cmax,ss of TSR-042
Cycle 11, n=6
|
446.6667 Microgram per milliliter
Standard Deviation 160.53868
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=4 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=4 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Cmax,ss of Niraparib
Cycle 2, n=4,4
|
0.854500 Microgram per milliliter
Standard Deviation 0.3934637
|
1.404750 Microgram per milliliter
Standard Deviation 0.6642366
|
|
Part C: Cmax,ss of Niraparib
Cycle 5, n=4,3
|
0.709750 Microgram per milliliter
Standard Deviation 0.2693788
|
1.073667 Microgram per milliliter
Standard Deviation 0.5474124
|
|
Part C: Cmax,ss of Niraparib
Cycle 11, n=3,1
|
0.468333 Microgram per milliliter
Standard Deviation 0.1418955
|
0.638000 Microgram per milliliter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Cmax,ss of TSR-042
Cycle 4, n=5,7
|
234.4000 Microgram per milliliter
Standard Deviation 31.76948
|
227.1429 Microgram per milliliter
Standard Deviation 42.65923
|
|
Part C: Cmax,ss of TSR-042
Cycle 5, n=5,6
|
325.2000 Microgram per milliliter
Standard Deviation 73.90332
|
417.3333 Microgram per milliliter
Standard Deviation 139.40397
|
|
Part C: Cmax,ss of TSR-042
Cycle 11, n=4,2
|
349.7500 Microgram per milliliter
Standard Deviation 111.53886
|
321.0000 Microgram per milliliter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Cmax,ss of TSR-042
Cycle 4, n=5
|
256.8000 Microgram per milliliter
Standard Deviation 76.90709
|
—
|
|
Part D: Cmax,ss of TSR-042
Cycle 5, n=5
|
416.0000 Microgram per milliliter
Standard Deviation 89.43433
|
—
|
|
Part D: Cmax,ss of TSR-042
Cycle 11, n=4
|
429.7500 Microgram per milliliter
Standard Deviation 72.86231
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Cmax,ss of TSR-042
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Cmax,ss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Cmax,ss of TSR-042
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Cmax,ss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Cmax,ss of TSR-022
|
NA Microgram per milliliter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Cmax,ss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=15 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib
|
2.250 Hours
Interval 1.75 to 7.02
|
4.083 Hours
Interval 2.02 to 25.65
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Tmax of TSR-042
|
0.817 Hours
Interval 0.5 to 2.58
|
1.750 Hours
Interval 0.5 to 23.17
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=14 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Tmax of TSR-042
|
1.000 Hours
Interval 0.55 to 27.28
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Tmax of Niraparib
|
3.975 Hours
Interval 2.0 to 23.33
|
4.050 Hours
Interval 2.05 to 22.6
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Tmax of TSR-042
|
1.200 Hours
Interval 0.5 to 4.48
|
0.583 Hours
Interval 0.5 to 2.35
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=6 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Tmax of TSR-042
|
1.250 Hours
Interval 0.5 to 25.17
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Tmax of TSR-042
|
NA Hours
Data was not collected due to insufficient number of participants with data to calculate Tmax.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Tmax of TSR-042
|
NA Hours
Data was not collected due to insufficient number of participants with data to calculate Tmax.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Tmax of TSR-022
|
NA Hours
Data was not collected due to insufficient number of participants with data to calculate Tmax.
|
—
|
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=10 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=3 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Tmax at Steady State (Tmax,ss) of Niraparib
Cycle 2, n=10,3
|
4.008 Hours
Interval 1.0 to 22.68
|
2.250 Hours
Interval 2.08 to 7.0
|
|
Part A: Tmax at Steady State (Tmax,ss) of Niraparib
Cycle 5, n=7,0
|
2.000 Hours
Interval 0.0 to 2.0
|
—
|
|
Part A: Tmax at Steady State (Tmax,ss) of Niraparib
Cycle 11, n=2,0
|
1.817 Hours
Interval 1.75 to 1.88
|
—
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=9 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=4 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Tmax,ss of TSR-042
Cycle 4, n=9,4
|
1.500 Hours
Interval 0.5 to 2.07
|
1.300 Hours
Interval 0.5 to 2.7
|
|
Part A: Tmax,ss of TSR-042
Cycle 5, n=8,1
|
0.625 Hours
Interval 0.5 to 1.73
|
2.783 Hours
Full range is not applicable due to single participant, and the median value presented here is the actual tmax,ss for this single participant.
|
|
Part A: Tmax,ss of TSR-042
Cycle 11, n=5,0
|
0.567 Hours
Interval 0.5 to 2.0
|
—
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=10 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Tmax,ss of TSR-042
Cycle 4, n=10
|
0.575 Hours
Interval 0.5 to 2.08
|
—
|
|
Part B: Tmax,ss of TSR-042
Cycle 5, n=9
|
1.500 Hours
Interval 0.5 to 2.1
|
—
|
|
Part B: Tmax,ss of TSR-042
Cycle 11, n=6
|
0.542 Hours
Interval 0.42 to 2.07
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=4 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=4 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Tmax,ss of Niraparib
Cycle 2, n=4,4
|
4.950 Hours
Interval 2.03 to 22.3
|
3.958 Hours
Interval 2.0 to 6.0
|
|
Part C: Tmax,ss of Niraparib
Cycle 5, n=4,3
|
2.158 Hours
Interval 1.82 to 2.68
|
1.967 Hours
Interval 1.17 to 2.0
|
|
Part C: Tmax,ss of Niraparib
Cycle 11, n=3,1
|
2.000 Hours
Interval 0.0 to 2.0
|
2.083 Hours
Full range is not applicable due to single participant, and the median value presented here is the actual tmax,ss for this single participant.
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=7 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Tmax,ss of TSR-042
Cycle 4, n=5,7
|
1.517 Hours
Interval 0.5 to 20.67
|
0.617 Hours
Interval 0.5 to 2.0
|
|
Part C: Tmax,ss of TSR-042
Cycle 5, n=5,6
|
2.083 Hours
Interval 0.5 to 2.58
|
0.825 Hours
Interval 0.5 to 2.25
|
|
Part C: Tmax,ss of TSR-042
Cycle 11, n=4,2
|
2.000 Hours
Interval 1.98 to 2.0
|
2.417 Hours
Interval 2.17 to 2.67
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Tmax,ss of TSR-042
Cycle 4, n=5
|
0.500 Hours
Interval 0.5 to 2.0
|
—
|
|
Part D: Tmax,ss of TSR-042
Cycle 5, n=5
|
0.550 Hours
Interval 0.5 to 2.0
|
—
|
|
Part D: Tmax,ss of TSR-042
Cycle 11, n=4
|
0.500 Hours
Interval 0.5 to 0.5
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Tmax,ss of TSR-042
|
NA Hours
Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Tmax,ss of TSR-042
|
NA Hours
Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Tmax,ss of TSR-022
|
NA Hours
Data was not collected due to insufficient number of participants with data to calculate Tmax,ss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=8 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=2 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042
Cycle 4, n=5,2
|
5.5647 Liter
Standard Deviation 1.36694
|
9.8680 Liter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
|
Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042
Cycle 5, n=8,1
|
6.6580 Liter
Standard Deviation 1.53521
|
5.9659 Liter
Standard Deviation NA
Standard deviation could not be calculated for single participant.
|
|
Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042
Cycle 11, n=4,0
|
7.3107 Liter
Standard Deviation 0.96007
|
—
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=10 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part B: Vss of TSR-042
Cycle 4, n=10
|
5.1893 Liter
Standard Deviation 1.80311
|
—
|
|
Part B: Vss of TSR-042
Cycle 5, n=8
|
6.7701 Liter
Standard Deviation 2.31992
|
—
|
|
Part B: Vss of TSR-042
Cycle 11, n=6
|
7.4351 Liter
Standard Deviation 2.78481
|
—
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 Participants
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part C: Vss of TSR-042
Cycle 4, n=5,5
|
6.4567 Liter
Standard Deviation 2.68944
|
5.5177 Liter
Standard Deviation 2.39652
|
|
Part C: Vss of TSR-042
Cycle 5, n=4,6
|
6.2405 Liter
Standard Deviation 1.79539
|
4.8035 Liter
Standard Deviation 0.72905
|
|
Part C: Vss of TSR-042
Cycle 11, n=4,2
|
8.9478 Liter
Standard Deviation 3.05769
|
7.7750 Liter
Standard Deviation NA
Standard deviation was not calculated as it is not statistically meaningful as there are only 2 participants.
|
SECONDARY outcome
Timeframe: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)Population: PK Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=5 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part D: Vss of TSR-042
Cycle 4, n=5
|
5.1493 Liter
Standard Deviation 1.58340
|
—
|
|
Part D: Vss of TSR-042
Cycle 5, n=5
|
5.6399 Liter
Standard Deviation 1.41478
|
—
|
|
Part D: Vss of TSR-042
Cycle 11, n=3
|
8.0614 Liter
Standard Deviation 0.48037
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=2 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part E: Vss of TSR-042
|
NA Liter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Vss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Vss of TSR-042
|
NA Liter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Vss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population.
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Outcome measures
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=1 Participants
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
|---|---|---|
|
Part F: Vss of TSR-022
|
NA Liter
Standard Deviation NA
Data was not collected due to insufficient number of participants with data to calculate Vss.
|
—
|
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part G.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part H.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)Population: PK Population. Data was not collected as no participants were enrolled in Part I.
Blood samples were planned to be collected at indicated time points.
Outcome measures
Outcome data not reported
Adverse Events
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
Serious events: 11 serious events
Other events: 16 other events
Deaths: 4 deaths
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
Serious events: 9 serious events
Other events: 14 other events
Deaths: 7 deaths
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
Serious events: 3 serious events
Other events: 7 other events
Deaths: 5 deaths
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Serious events: 3 serious events
Other events: 6 other events
Deaths: 1 deaths
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 participants at risk
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
n=14 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
|
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
n=6 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
n=7 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
n=6 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
n=2 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
|
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
n=1 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
|
PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel
n=2 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
|
PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
n=1 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Asthenia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Fatigue
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Mucosal inflammation
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Sudden death
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Hepatobiliary disorders
Hepatitis
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Vertebral artery dissection
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
2/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
General Medical Deterioration
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
Other adverse events
| Measure |
Main Study: Part A: TSR-042 and Niraparib 200 mg QD
n=16 participants at risk
Participants received TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part A: TSR-042 and Niraparib 300 mg QD
n=6 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
|
Main Study: Part B: TSR-042 and Carboplatin-paclitaxel
n=14 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
|
Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab
n=6 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab
n=7 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
n=6 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
Main Study: Part E: TSR-042 and Carboplatin-pemetrexed
n=2 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for approximately 6 cycles (each cycle was of 21 days).
|
Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed
n=1 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for approximately 5 cycles (each cycle was of 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
|
PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel
n=2 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
|
PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab
n=1 participants at risk
Participants received TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle was of 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
4/16 • Number of events 13 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
71.4%
10/14 • Number of events 27 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
71.4%
5/7 • Number of events 10 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
83.3%
5/6 • Number of events 10 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
2/2 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 12 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
1/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
42.9%
6/14 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
66.7%
4/6 • Number of events 15 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
4/16 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 19 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Cardiac disorders
Palpitations
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Cardiac disorders
Tachycardia
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Ear and labyrinth disorders
Vertigo
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Endocrine disorders
Hyperthyroidism
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Endocrine disorders
Hypothyroidism
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Eye disorders
Blepharitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Eye disorders
Diplopia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Eye disorders
Vision blurred
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
21.4%
3/14 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Eye disorders
Visual impairment
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
4/16 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Ascites
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Colitis
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Constipation
|
31.2%
5/16 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
4/14 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
66.7%
4/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
57.1%
4/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
2/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
42.9%
6/14 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
57.1%
4/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
66.7%
4/6 • Number of events 21 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Gastric disorder
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Hypertrophy of tongue papillae
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Inguinal hernia
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
8/16 • Number of events 10 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
66.7%
4/6 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
4/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
57.1%
4/7 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
2/2 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Gastrointestinal disorders
Vomiting
|
31.2%
5/16 • Number of events 11 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
57.1%
4/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Asthenia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
21.4%
3/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Chest discomfort
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Chest pain
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Cyst rupture
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Fatigue
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
7/14 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
57.1%
4/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
66.7%
4/6 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Gait disturbance
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Localised oedema
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Malaise
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Mucosal inflammation
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Oedema peripheral
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
21.4%
3/14 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Pain
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Peripheral swelling
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Pyrexia
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Swelling
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Swelling face
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
General disorders
Temperature intolerance
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Bacterial vulvovaginitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Candida infection
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
4/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Cystitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Oral candidiasis
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Sinusitis
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Stoma site infection
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
18.8%
3/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
4/14 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Viral pharyngitis
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Injury, poisoning and procedural complications
Radiation injury
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Injury, poisoning and procedural complications
Recall phenomenon
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Alanine aminotransferase increased
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Amylase increased
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Aspartate aminotransferase increased
|
18.8%
3/16 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.5%
2/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Blood creatinine increased
|
12.5%
2/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Blood folate decreased
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Blood pressure increased
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Blood testosterone decreased
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Breath sounds abnormal
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Cardiac murmur
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Platelet count decreased
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Tri-iodothyronine decreased
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Vitamin B12 decreased
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Weight decreased
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
Weight increased
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Investigations
White blood cell count decreased
|
12.5%
2/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
35.7%
5/14 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
42.9%
3/7 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
4/16 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
4/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 8 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
2/2 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.2%
1/16 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
31.2%
5/16 • Number of events 8 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
35.7%
5/14 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
4/14 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Metabolism and nutrition disorders
Malnutrition
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
42.9%
6/14 • Number of events 11 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
4/14 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Dizziness postural
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
21.4%
3/14 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Headache
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
21.4%
3/14 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
66.7%
4/6 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Hyperreflexia
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
4/14 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Syncope
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Nervous system disorders
Tremor
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Product Issues
Device malfunction
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Product Issues
Device occlusion
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Psychiatric disorders
Anxiety
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Psychiatric disorders
Insomnia
|
18.8%
3/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
4/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Psychiatric disorders
Sleep disorder
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Renal and urinary disorders
Haematuria
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Renal and urinary disorders
Nocturia
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Renal and urinary disorders
Proteinuria
|
6.2%
1/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
57.1%
4/7 • Number of events 9 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
4/16 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
21.4%
3/14 • Number of events 8 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
4/16 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
21.4%
3/14 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
4/16 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
42.9%
6/14 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated pneumonitis
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
2/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
57.1%
8/14 • Number of events 10 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
83.3%
5/6 • Number of events 6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
6.2%
1/16 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Vascular disorders
Hot flush
|
6.2%
1/16 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Vascular disorders
Hypertension
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
66.7%
4/6 • Number of events 4 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
28.6%
2/7 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
3/6 • Number of events 5 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Vascular disorders
Hypotension
|
12.5%
2/16 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
16.7%
1/6 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
33.3%
2/6 • Number of events 3 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
100.0%
1/1 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
2/14 • Number of events 2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Vascular disorders
Pallor
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/14 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
14.3%
1/7 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/16 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
7.1%
1/14 • Number of events 1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/7 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/6 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/2 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
0.00%
0/1 • All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.
Safety Population consisted of all participants who received any amount of study treatment. Data is presented for Parts A to F only as data was not collected for Parts G, H, and I. Parts G, H and I were not initiated due to business strategic reason. MedDRA version (v) used for Arm A and F was 23.0 and Arm B to E is 25.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER