Trial Outcomes & Findings for Study of Surzebiclimab (BGB-A425) and Alcestobart (LBL-007) in Combination With Tislelizumab in Advanced Solid Tumors (NCT NCT03744468)
NCT ID: NCT03744468
Last Updated: 2026-04-02
Results Overview
An Adverse Event (AE) was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
147 participants
Primary outcome timeframe
Up to 30 days after last dose of study drug (maximum treatment duration: up to 32.7 months)
Results posted on
2026-04-02
Participant Flow
Based on the interim analysis of Cohorts 1, 2, 4, 5 in dose expansion, sponsor decided not to further investigate the combinations in renal cell carcinoma (RCC) and to not investigate alcestobart (LBL-007), double or triple treatment combination in programmed cell death protein-1 (PD-1) resistant non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). Hence, Phase 2 (Dose Expansion) Cohorts 3, 6 and 7 were planned, but not initiated based on sponsor's decision.
Participant milestones
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 Milligrams (mg) + Tislelizumab
Participants received surzebiclimab 2 mg intravenous (IV) infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab
Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + BGB-A425 + Tislelizumab
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab
Participants received alcestobart 900 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab
Participants with head and neck squamous cell carcinoma (HNSCC) received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab
Participants with non-small cell lung cancer (NSCLC) received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
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Overall Study
STARTED
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5
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7
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7
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3
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1
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1
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4
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6
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6
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3
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6
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6
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21
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22
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20
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20
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Overall Study
COMPLETED
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0
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0
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2
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1
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5
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2
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4
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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
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Overall Study
NOT COMPLETED
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1
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1
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4
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2
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2
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3
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1
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1
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6
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6
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3
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6
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6
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21
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22
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20
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20
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Reasons for withdrawal
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 Milligrams (mg) + Tislelizumab
Participants received surzebiclimab 2 mg intravenous (IV) infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab
Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + BGB-A425 + Tislelizumab
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab
Participants received alcestobart 900 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab
Participants with head and neck squamous cell carcinoma (HNSCC) received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab
Participants with non-small cell lung cancer (NSCLC) received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Overall Study
Death
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1
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1
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0
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1
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1
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2
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1
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1
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1
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0
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2
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3
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2
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0
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3
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4
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15
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11
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11
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8
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Overall Study
Lost to Follow-up
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0
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0
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0
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2
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1
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0
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1
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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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1
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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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Overall Study
Physician Decision
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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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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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1
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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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Overall Study
Sponsor Decision
|
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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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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Overall Study
Withdrawal by Subject
|
0
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0
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0
|
1
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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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1
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2
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0
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0
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0
|
4
|
8
|
2
|
1
|
|
Overall Study
Other
|
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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0
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2
|
2
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1
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2
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3
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2
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2
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3
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7
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11
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Baseline Characteristics
Study of Surzebiclimab (BGB-A425) and Alcestobart (LBL-007) in Combination With Tislelizumab in Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab
n=6 Participants
Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received BGB-A425 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
n=1 Participants
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
n=1 Participants
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab
n=4 Participants
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab
n=6 Participants
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + Surzebiclimab + Tislelizumab
n=3 Participants
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab
n=6 Participants
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab
n=6 Participants
Participants received alcestobart 900 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab
n=21 Participants
Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab
n=22 Participants
Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
n=20 Participants
Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
n=20 Participants
Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 9.32 • n=30 Participants
|
66.0 years
n=5 Participants
|
66.0 years
n=5 Participants
|
53.3 years
STANDARD_DEVIATION 20.84 • n=10 Participants
|
60.6 years
STANDARD_DEVIATION 7.80 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 8.57 • n=11 Participants
|
58.8 years
STANDARD_DEVIATION 4.19 • n=13 Participants
|
58.7 years
STANDARD_DEVIATION 9.79 • n=48 Participants
|
45.3 years
STANDARD_DEVIATION 15.95 • n=3 Participants
|
47.0 years
n=4 Participants
|
56.0 years
n=37 Participants
|
61.0 years
STANDARD_DEVIATION 8.16 • n=323 Participants
|
65.3 years
STANDARD_DEVIATION 7.99 • n=210 Participants
|
61.3 years
STANDARD_DEVIATION 16.07 • n=30 Participants
|
61.5 years
STANDARD_DEVIATION 13.50 • n=30 Participants
|
65.5 years
STANDARD_DEVIATION 6.66 • n=482 Participants
|
60.9 years
STANDARD_DEVIATION 7.91 • n=159 Participants
|
64.5 years
STANDARD_DEVIATION 7.52 • n=321 Participants
|
64.2 years
STANDARD_DEVIATION 9.57 • n=20 Participants
|
65.4 years
STANDARD_DEVIATION 9.18 • n=20 Participants
|
62.4 years
STANDARD_DEVIATION 9.50 • n=20 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=30 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=11 Participants
|
4 Participants
n=13 Participants
|
3 Participants
n=48 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=37 Participants
|
3 Participants
n=323 Participants
|
3 Participants
n=210 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=482 Participants
|
2 Participants
n=159 Participants
|
8 Participants
n=321 Participants
|
7 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
57 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=30 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
4 Participants
n=48 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=323 Participants
|
3 Participants
n=210 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
3 Participants
n=482 Participants
|
19 Participants
n=159 Participants
|
14 Participants
n=321 Participants
|
13 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
90 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=30 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=323 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=482 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=321 Participants
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=30 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=11 Participants
|
4 Participants
n=13 Participants
|
7 Participants
n=48 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=37 Participants
|
4 Participants
n=323 Participants
|
5 Participants
n=210 Participants
|
3 Participants
n=30 Participants
|
6 Participants
n=30 Participants
|
5 Participants
n=482 Participants
|
21 Participants
n=159 Participants
|
22 Participants
n=321 Participants
|
17 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
137 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=323 Participants
|
1 Participants
n=210 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=482 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=321 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=323 Participants
|
0 Participants
n=210 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=482 Participants
|
6 Participants
n=159 Participants
|
14 Participants
n=321 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
27 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=30 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=323 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=482 Participants
|
1 Participants
n=159 Participants
|
1 Participants
n=321 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=30 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=11 Participants
|
3 Participants
n=13 Participants
|
7 Participants
n=48 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=37 Participants
|
3 Participants
n=323 Participants
|
5 Participants
n=210 Participants
|
2 Participants
n=30 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=482 Participants
|
14 Participants
n=159 Participants
|
7 Participants
n=321 Participants
|
9 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
98 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=323 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=482 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=321 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=30 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=323 Participants
|
1 Participants
n=210 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=482 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=321 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=30 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=323 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=482 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=321 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=30 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=323 Participants
|
0 Participants
n=210 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=482 Participants
|
0 Participants
n=159 Participants
|
0 Participants
n=321 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after last dose of study drug (maximum treatment duration: up to 32.7 months)Population: Analysis was performed on safety analysis set.
An Adverse Event (AE) was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
n=1 Participants
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
n=1 Participants
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Any TEAE
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Grade 3 or above TEAE
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Serious TEAE
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Analysis was performed on dose limiting toxicities (DLT) evaluable analysis set that included all participants who received at least 80% each of the assigned dose of surzebiclimab on Cycle 1 Day 1 and tislelizumab on Cycle 1 Day 8 and remained on the study during the 28-day DLT observation period for safety evaluation.
The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 1, therefore the MAD was reported.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=33 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Surzebiclimab in Combination With Tislelizumab
|
1600 milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: Analysis was performed on all Phase 1 participants.
The RP2D or recommended dose for expansion of the combination treatment was determined based upon the MTD or MAD, and also considered the long-term tolerability, PK, efficacy, and any other relevant data as available.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=33 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Recommended Phase 2 Dose (RP2D) of Surzebiclimab in Combination With Tislelizumab
|
600 milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 30 days after last dose of study drug (maximum duration of treatment: up to 19.6 months in Cohort A and up to 21.5 months in Cohort B)Population: Analysis was performed on safety analysis set.
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Severity of AEs was assessed according to NCI-CTCAE v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): Number of Participants With TEAEs and SAEs
Serious AE
|
3 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): Number of Participants With TEAEs and SAEs
Grade 3 or above TEAE
|
3 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): Number of Participants With TEAEs and SAEs
Any TEAE
|
4 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: Analysis was performed on DLT evaluable analysis set that included all participants who received at least 80% each of the assigned dose of study drug(s) in the combination treatments and remained on the study during the 21-day DLT observation period for safety evaluation.
The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 2, therefore the MAD was reported.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=16 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): MTD or MAD of Alcestobart in Combination With Tislelizumab
|
1200 milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: Analysis was performed on DLT evaluable analysis set. Here, 'overall number of participants analyzed' signifies participants with data available for the analysis.
The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 2, therefore the MAD was reported.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=15 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): MTD or MAD of Alcestobart in Combination With Surzebiclimab and Tislelizumab
|
900 milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: Analysis was performed on DLT evaluable analysis set in Phase 2 participants. Here, 'Overall number of participants analyzed' signifies participants with data available for the analysis.
The RP2D or recommended dose for expansion of the combination treatment was determined based upon the MTD or MAD, and also considered the long-term tolerability, PK, efficacy, and any other relevant data as available.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=15 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): RP2D of Alcestobart in Combination With Surzebiclimab and Tislelizumab
|
600 milligram (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to11.3 months, Cohort 5: up to 15.9 monthsPopulation: Analysis was performed on efficacy evaluable analysis set that included all dosed participants who had evaluable disease at baseline, and at least 1 evaluable postbaseline tumor response assessment unless any clinical progression of disease (PD) or death occurred before the first scheduled postbaseline tumor assessment.
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=21 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=22 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=19 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Overall Response Rate (ORR)
|
4.8 percentage of participants
Interval 0.1 to 23.8
|
9.1 percentage of participants
Interval 1.1 to 29.2
|
0.0 percentage of participants
Interval 0.0 to 16.8
|
10.5 percentage of participants
Interval 1.3 to 33.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: up to 57.5 monthsPopulation: Analysis was performed on efficacy evaluable analysis set. The participant in the 'Phase 1 (Dose Escalation): Surzebiclimab 1600 mg' cohort was not included in the efficacy evaluable analysis set.
ORR was defined as the percentage of participants who had CR or PR. Per RECIST v.1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
n=1 Participants
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Overall Response Rate (ORR)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
0.0 percentage of participants
Interval 0.0 to 52.2
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 monthsPopulation: Analysis was performed on efficacy evaluable analysis set.
ORR was defined as the percentage of participants who had CR or PR. Per RECIST v.1.1, CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead- In): Overall Response Rate (ORR)
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: up to 57.5 monthsPopulation: Analysis was performed on efficacy evaluable analysis set. The participant in the 'Phase 1 (Dose Escalation): Surzebiclimab 1600 mg' cohort was not included in the efficacy evaluable analysis set.
DCR was defined as the percentage of participants with a best overall response (BOR) of CR, PR, or stable disease (SD), per RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
n=1 Participants
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Disease Control Rate (DCR)
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
57.1 percentage of participants
Interval 18.4 to 90.1
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 monthsPopulation: Analysis was performed on efficacy evaluable analysis set.
DCR was defined as the percentage of participants with a BOR of CR, PR, or SD, per RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): Disease Control Rate (DCR)
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 monthsPopulation: Analysis was performed on efficacy evaluable analysis set.
DCR was defined as the percentage of participants with a BOR of CR, PR, or SD, per RECIST v.1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=21 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=22 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=19 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Disease Control Rate (DCR)
|
42.9 percentage of participants
Interval 21.8 to 66.0
|
45.5 percentage of participants
Interval 24.4 to 67.8
|
45.0 percentage of participants
Interval 23.1 to 68.5
|
73.7 percentage of participants
Interval 48.8 to 90.9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first determination of an overall response until PD or death, whichever came first (Maximum time on study [Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months])Population: Analysis was performed on efficacy evaluable analysis set on participants who had an overall response. Here, 'Overall number of participants analyzed' = participants with available data for analysis and "0" in the overall number of participants analyzed signifies no participants with available data.
DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression or death, whichever came first. DOR was estimated using the Kaplan-Meier method. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=2 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=2 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Duration of Response (DOR)
|
4.0 months
|
6.9 months
Interval 5.6 to
Upper limit of 95% confidence interval (CI) could not be calculated due to insufficient number of participants with events.
|
—
|
NA months
Interval 2.8 to
Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 monthsPopulation: Analysis was performed on safety analysis set.
Progression free survival was defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of disease progression assessed by investigator or death, whichever occurred first as determined from investigator derived tumor assessments per RECIST 1.1. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=21 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=22 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Progression Free Survival (PFS)
|
1.4 months
Interval 1.4 to 2.6
|
1.7 months
Interval 1.3 to 4.0
|
1.9 months
Interval 1.2 to 2.8
|
4.0 months
Interval 1.4 to 7.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI; within 30 minutes), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI. Cycle 1 was 28 days and Cycle 5 was 21 days.Population: Analysis was performed on the Pharmacokinetic (PK) analysis set which included all participants who received at least 1 dose of study drug and had at least 1 derivable PK parameter for surzebiclimab. The 'Number Analyzed' = participants with available data for the specified cycle; "0" signifies there were no participants with available data.
The maximum observed plasma concentration of surzebiclimab was measured in Cycle 1 and Cycle 5.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
n=1 Participants
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
n=1 Participants
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Surzebiclimab
Cycle 5 Day 1
|
—
|
—
|
6.96 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 17
|
26.62 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 65
|
123.87 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 14
|
222.86 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 45
|
470.02 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 19
|
885.00 micrograms per milliliter (mcg/mL)
|
—
|
—
|
|
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Surzebiclimab
Cycle 1 Day 1
|
—
|
0.89 micrograms per milliliter (mcg/mL)
|
5.48 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 24
|
17.43 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 38
|
66.50 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 25
|
145.09 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 20
|
244.03 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 25
|
604.10 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 9
|
19.20 micrograms per milliliter (mcg/mL)
|
534.00 micrograms per milliliter (mcg/mL)
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)Population: In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5. The analysis was performed on the PK analysis set. The Number Analyzed = participants with available data at each cycle; "0" signifies there were no participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=2 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=11 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Cmax of Surzebiclimab
Cycle 1 Day 1
|
182.24 mcg/mL
Geometric Coefficient of Variation 17
|
165.62 mcg/mL
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Cmax of Surzebiclimab
Cycle 5 Day 1
|
—
|
288.43 mcg/mL
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI (Cycle 1 was 28 days; Cycle 2 and thereafter were 21 days)Population: Analysis was performed on the PK analysis set. The 'Number analyzed' = participants with available data for the specified cycle and "0" signifies no participants with available data.
Cmin of surzebiclimab was determined.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=2 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Minimum Observed Plasma Concentration (Cmin) of Surzebiclimab
Cycle 1 Day 1
|
—
|
—
|
—
|
1.80 mcg/mL
Geometric Coefficient of Variation 80
|
14.55 mcg/mL
Geometric Coefficient of Variation 49
|
27.84 mcg/mL
Geometric Coefficient of Variation 39
|
62.46 mcg/mL
Geometric Coefficient of Variation 33
|
167.44 mcg/mL
Geometric Coefficient of Variation 27
|
—
|
—
|
|
Phase 1: Minimum Observed Plasma Concentration (Cmin) of Surzebiclimab
Cycle 5 Day 1
|
—
|
—
|
0.47 mcg/mL
|
6.38 mcg/mL
Geometric Coefficient of Variation 46
|
54.06 mcg/mL
Geometric Coefficient of Variation 8
|
57.43 mcg/mL
Geometric Coefficient of Variation 117
|
173.58 mcg/mL
Geometric Coefficient of Variation 19
|
537.02 mcg/mL
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOIPopulation: In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5. The analysis was performed on the PK analysis set. The 'Number Analyzed' = participants with available data at each cycle; "0" signifies no participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=2 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=9 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Cmin of Surzebiclimab
Cycle 1 Day 1
|
40.24 mcg/mL
Geometric Coefficient of Variation 26
|
32.27 mcg/mL
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Cmin of Surzebiclimab
Cycle 5 Day 1
|
116.05 mcg/mL
|
87.92 mcg/mL
Geometric Coefficient of Variation 51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 (cycle 1 only) days after EOI (Cycle 1 was28 days; Cycle 2 and thereafter were 21 days)Population: Analysis was performed on the PK analysis set. The 'Number analyzed' = participants with available data for the specified cycle and "0" signifies there were no participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
n=1 Participants
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
n=1 Participants
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Surzebiclimab
Cycle 1 Day 1
|
—
|
1.30 hours
Interval 1.3 to 1.3
|
1.33 hours
Interval 1.1 to 6.1
|
1.15 hours
Interval 1.0 to 1.2
|
1.20 hours
Interval 1.0 to 5.1
|
1.15 hours
Interval 1.0 to 5.2
|
1.10 hours
Interval 1.1 to 6.3
|
1.22 hours
Interval 1.2 to 6.6
|
5.02 hours
|
1.58 hours
|
|
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Surzebiclimab
Cycle 5 Day 1
|
—
|
—
|
2.93 hours
Interval 0.7 to 5.2
|
0.72 hours
Interval 0.7 to 0.8
|
0.57 hours
Interval 0.5 to 0.6
|
5.66 hours
Interval 4.7 to 6.6
|
0.92 hours
Interval 0.6 to 6.7
|
0.62 hours
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)Population: In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5. The analysis was performed on the PK analysis set. The 'Number Analyzed' = participants with available data at each cycle; "0" signifies there were no participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=2 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=11 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Tmax of Surzebiclimab
Cycle 1 Day 1
|
4.54 hours
Interval 4.1 to 5.0
|
4.00 hours
Interval 1.0 to 23.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Tmax of Surzebiclimab
Cycle 5 Day 1
|
—
|
2.78 hours
Interval 0.5 to 22.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)Population: Analysis was performed on the PK analysis set. 'Overall number of participants analyzed' = participants with available data for analysis and "0" signifies there were no participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=2 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
n=1 Participants
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Half-Life (t1/2) of Surzebiclimab
|
—
|
—
|
122.20 hours
Interval 117.9 to 126.5
|
203.43 hours
Interval 139.2 to 246.1
|
276.06 hours
Interval 174.4 to 628.5
|
344.59 hours
Interval 338.2 to 674.2
|
356.26 hours
Interval 327.9 to 512.2
|
643.02 hours
|
—
|
99.20 hours
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)Population: In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5. The analysis was performed on the PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=10 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): T1/2 of Surzebiclimab
|
325.65 hours
Interval 224.5 to 523.7
|
274.83 hours
Interval 216.5 to 462.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (Cycle 1 was 28 days; Cycle 2 and thereafter were 21 days)Population: Analysis was performed on the PK analysis set. The 'Number analyzed' = participants with available data for the specified cycle and "0" signifies there were no participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=2 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
n=1 Participants
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Area Under Curve From 0 to 21 Days (AUC0-21d) of Surzebiclimab
Cycle 1 Day 1
|
—
|
—
|
727.11 hours*mcg/mL
Geometric Coefficient of Variation 31
|
2734.25 hours*mcg/mL
Geometric Coefficient of Variation 44
|
12911.99 hours*mcg/mL
Geometric Coefficient of Variation 34
|
25213.19 hours*mcg/mL
Geometric Coefficient of Variation 30
|
50478.81 hours*mcg/mL
Geometric Coefficient of Variation 25
|
153224.06 hours*mcg/mL
|
—
|
70304.42 hours*mcg/mL
|
|
Phase 1: Area Under Curve From 0 to 21 Days (AUC0-21d) of Surzebiclimab
Cycle 5 Day 1
|
—
|
—
|
999.31 hours*mcg/mL
Geometric Coefficient of Variation 36
|
5518.62 hours*mcg/mL
Geometric Coefficient of Variation 29
|
38776.66 hours*mcg/mL
Geometric Coefficient of Variation 1
|
34857.77 hours*mcg/mL
|
138368.71 hours*mcg/mL
Geometric Coefficient of Variation 20
|
303366.23 hours*mcg/mL
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle duration= 21 days)Population: In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5. The analysis was performed on the PK analysis set. The 'Number Analyzed' = participants with available data at each cycle; "0" signifies there were no participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=10 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): AUC0-21d of Surzebiclimab
Cycle 1 Day 1
|
37538.32 hours*mcg/mL
Geometric Coefficient of Variation 15
|
31104.68 hours*mcg/mL
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): AUC0-21d of Surzebiclimab
Cycle 5 Day 1
|
90437.84 hours*mcg/mL
|
66659.54 hours*mcg/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)Population: Analysis was performed on the PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis and "0" signifies there were no participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=2 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
n=1 Participants
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Clearance (CL/F) of Surzebiclimab
|
—
|
—
|
0.03 Liters per hour (L/h)
Geometric Coefficient of Variation 28
|
0.02 Liters per hour (L/h)
Geometric Coefficient of Variation 50
|
0.01 Liters per hour (L/h)
Geometric Coefficient of Variation 57
|
0.01 Liters per hour (L/h)
Geometric Coefficient of Variation 42
|
0.01 Liters per hour (L/h)
Geometric Coefficient of Variation 11
|
0.00 Liters per hour (L/h)
|
—
|
0.02 Liters per hour (L/h)
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOIPopulation: In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5. The analysis was performed on the PK analysis set. The Overall Number of Participants Analyzed = participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=10 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): CL/F of Surzebiclimab
|
0.01 Liters per hour (L/h)
Geometric Coefficient of Variation 21
|
0.01 Liters per hour (L/h)
Geometric Coefficient of Variation 38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, 21, and 28 days after EOI (Cycle 1 was 28 days)Population: Analysis was performed on the PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis; "0" signifies there were no participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=2 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
n=1 Participants
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Volume of Distribution (Vz/F) of Surzebiclimab
|
—
|
—
|
4.43 Liters (L)
Geometric Coefficient of Variation 33
|
5.04 Liters (L)
Geometric Coefficient of Variation 37
|
4.48 Liters (L)
Geometric Coefficient of Variation 22
|
5.55 Liters (L)
Geometric Coefficient of Variation 30
|
5.56 Liters (L)
Geometric Coefficient of Variation 34
|
4.38 Liters (L)
|
—
|
3.15 Liters (L)
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOIPopulation: In Phase 2 Dose Expansion, PK samples were only collected from a subset of participants in Cohorts 1 and 2, PK samples were not planned or collected from Cohorts 4 and 5. The analysis was performed on the PK analysis set. The Overall Number of Participants Analyzed = participants with available data.
Vz/F of surzebiclimab was determined.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=10 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Vz/F of Surzebiclimab
|
4.98 Liters (L)
Geometric Coefficient of Variation 33
|
5.69 Liters (L)
Geometric Coefficient of Variation 16
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)Population: Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data for the specified cycle.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): Cmax of Alcestobart
Cycle 1 Day 1
|
61.21 mcg/mL
Geometric Coefficient of Variation 51
|
112.96 mcg/mL
Geometric Coefficient of Variation 24
|
242.51 mcg/mL
Geometric Coefficient of Variation 19
|
61.39 mcg/mL
Geometric Coefficient of Variation 32
|
115.74 mcg/mL
Geometric Coefficient of Variation 25
|
149.57 mcg/mL
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): Cmax of Alcestobart
Cycle 5 Day 1
|
57.60 mcg/mL
|
177.18 mcg/mL
Geometric Coefficient of Variation 15
|
294.49 mcg/mL
Geometric Coefficient of Variation 17
|
86.40 mcg/mL
|
139.24 mcg/mL
Geometric Coefficient of Variation 9
|
245.81 mcg/mL
Geometric Coefficient of Variation 45
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)Population: Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data for the specified cycle and "0" signifies there were no participants with available data.
Cmin of alcestobart was determined.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): Cmin of Alcestobart
Cycle 1 Day 1
|
2.01 mcg/mL
Geometric Coefficient of Variation 300
|
24.07 mcg/mL
Geometric Coefficient of Variation 40
|
35.38 mcg/mL
Geometric Coefficient of Variation 27
|
9.32 mcg/mL
Geometric Coefficient of Variation 62
|
12.81 mcg/mL
Geometric Coefficient of Variation 43
|
26.44 mcg/mL
Geometric Coefficient of Variation 52
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): Cmin of Alcestobart
Cycle 5 Day 1
|
—
|
40.66 mcg/mL
Geometric Coefficient of Variation 30
|
77.79 mcg/mL
Geometric Coefficient of Variation 18
|
15.95 mcg/mL
|
32.55 mcg/mL
Geometric Coefficient of Variation 14
|
67.12 mcg/mL
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)Population: Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data for the specified cycle.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): Tmax of Alcestobart
Cycle 1 Day 1
|
1.48 hours
Interval 1.2 to 1.8
|
2.84 hours
Interval 1.4 to 5.4
|
1.54 hours
Interval 1.2 to 6.0
|
1.42 hours
Interval 1.3 to 4.3
|
1.29 hours
Interval 1.2 to 6.1
|
1.28 hours
Interval 1.0 to 1.8
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): Tmax of Alcestobart
Cycle 5 Day 1
|
0.83 hours
|
4.57 hours
Interval 0.9 to 22.0
|
11.97 hours
Interval 0.6 to 23.4
|
0.67 hours
|
4.18 hours
Interval 4.1 to 4.3
|
0.83 hours
Interval 0.7 to 1.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)Population: Analysis was performed on PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): t1/2 of Alcestobart
|
143.35 hours
Interval 56.5 to 214.8
|
248.79 hours
Interval 195.6 to 380.4
|
227.76 hours
Interval 188.8 to 284.1
|
230.84 hours
Interval 167.5 to 234.5
|
200.74 hours
Interval 152.4 to 255.5
|
262.83 hours
Interval 152.7 to 333.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 5 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOI (each cycle was 21 days)Population: Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data for the specified cycle and "0" signifies there were no participants with available data.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): AUC0-21d of Alcestobart
Cycle 1 Day 1
|
8620.04 hours*mcg/mL
Geometric Coefficient of Variation 34
|
21120.06 hours*mcg/mL
Geometric Coefficient of Variation 15
|
41874.14 hours*mcg/mL
Geometric Coefficient of Variation 26
|
10947.98 hours*mcg/mL
Geometric Coefficient of Variation 35
|
18655.37 hours*mcg/mL
Geometric Coefficient of Variation 25
|
30906.45 hours*mcg/mL
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): AUC0-21d of Alcestobart
Cycle 5 Day 1
|
—
|
41698.19 hours*mcg/mL
Geometric Coefficient of Variation 20
|
67245.59 hours*mcg/mL
Geometric Coefficient of Variation 20
|
16445.08 hours*mcg/mL
|
32044.03 hours*mcg/mL
Geometric Coefficient of Variation 12
|
49948.77 hours*mcg/mL
Geometric Coefficient of Variation 54
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOIPopulation: Analysis was performed on PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): CL/F of Alcestobart
|
0.03 L/h
Geometric Coefficient of Variation 37
|
0.02 L/h
Geometric Coefficient of Variation 31
|
0.02 L/h
Geometric Coefficient of Variation 26
|
0.02 L/h
Geometric Coefficient of Variation 40
|
0.03 L/h
Geometric Coefficient of Variation 26
|
0.02 L/h
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 at pre-dose, end of infusion (EOI), 6 hours, 1, 3, 7, 14, and 21 days after EOIPopulation: Analysis was performed on PK analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): Vz/F of Alcestobart
|
5.48 Liters
Geometric Coefficient of Variation 77
|
7.83 Liters
Geometric Coefficient of Variation 10
|
7.29 Liters
Geometric Coefficient of Variation 31
|
6.40 Liters
Geometric Coefficient of Variation 29
|
7.59 Liters
Geometric Coefficient of Variation 26
|
7.81 Liters
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and EOI (within 30 minutes) on Cycle 1 Day 8 and Cycle 5 Day 1, and pre-dose on Day 1 of Cycles 2, 3, 6, 9, 13, 17, and 25 (Cycle 1 was 28 days, Cycle 2 and thereafter were 21 days)Population: Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data for the specified time point and "0" signifies there were no participants with available data.
Serum concentrations of tislelizumab were measured using an enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Serum Concentrations of Tislelizumab
Cycle 1 Day 8: End of Infusion
|
40.50 mcg/mL
|
51.10 mcg/mL
|
57.91 mcg/mL
Geometric Coefficient of Variation 24
|
54.87 mcg/mL
Geometric Coefficient of Variation 46
|
64.19 mcg/mL
Geometric Coefficient of Variation 26
|
66.23 mcg/mL
Geometric Coefficient of Variation 25
|
67.66 mcg/mL
Geometric Coefficient of Variation 20
|
64.05 mcg/mL
Geometric Coefficient of Variation 15
|
—
|
—
|
|
Phase 1: Serum Concentrations of Tislelizumab
Cycle 1 Day 8: Pre-dose
|
—
|
—
|
—
|
—
|
0.68 mcg/mL
|
—
|
2.70 mcg/mL
|
—
|
—
|
—
|
|
Phase 1: Serum Concentrations of Tislelizumab
Cycle 2 Day 1: Pre-dose
|
12.20 mcg/mL
|
14.00 mcg/mL
|
28.29 mcg/mL
Geometric Coefficient of Variation 108
|
17.31 mcg/mL
Geometric Coefficient of Variation 24
|
17.75 mcg/mL
Geometric Coefficient of Variation 44
|
15.93 mcg/mL
Geometric Coefficient of Variation 37
|
16.68 mcg/mL
Geometric Coefficient of Variation 26
|
18.71 mcg/mL
Geometric Coefficient of Variation 38
|
—
|
—
|
|
Phase 1: Serum Concentrations of Tislelizumab
Cycle 3 Day 1: Pre-dose
|
—
|
—
|
27.60 mcg/mL
|
49.64 mcg/mL
Geometric Coefficient of Variation 201
|
34.83 mcg/mL
Geometric Coefficient of Variation 78
|
26.40 mcg/mL
Geometric Coefficient of Variation 79
|
28.20 mcg/mL
|
35.90 mcg/mL
|
—
|
—
|
|
Phase 1: Serum Concentrations of Tislelizumab
Cycle 5 Day 1: Pre-dose
|
—
|
—
|
34.50 mcg/mL
Geometric Coefficient of Variation 71
|
49.31 mcg/mL
Geometric Coefficient of Variation 18
|
64.82 mcg/mL
Geometric Coefficient of Variation 4
|
38.24 mcg/mL
Geometric Coefficient of Variation 81
|
44.59 mcg/mL
Geometric Coefficient of Variation 22
|
55.20 mcg/mL
|
—
|
—
|
|
Phase 1: Serum Concentrations of Tislelizumab
Cycle 5 Day 1: End of Infusion
|
—
|
—
|
82.60 mcg/mL
|
110.68 mcg/mL
Geometric Coefficient of Variation 26
|
122.85 mcg/mL
Geometric Coefficient of Variation 7
|
116.81 mcg/mL
Geometric Coefficient of Variation 53
|
100.66 mcg/mL
Geometric Coefficient of Variation 25
|
92.90 mcg/mL
|
—
|
—
|
|
Phase 1: Serum Concentrations of Tislelizumab
Cycle 6 Day 1: Pre-dose
|
—
|
—
|
46.58 mcg/mL
Geometric Coefficient of Variation 44
|
51.39 mcg/mL
Geometric Coefficient of Variation 35
|
69.54 mcg/mL
Geometric Coefficient of Variation 2
|
33.54 mcg/mL
Geometric Coefficient of Variation 87
|
41.83 mcg/mL
Geometric Coefficient of Variation 31
|
58.10 mcg/mL
|
—
|
—
|
|
Phase 1: Serum Concentrations of Tislelizumab
Cycle 9 Day 1: Pre-dose
|
—
|
—
|
57.95 mcg/mL
Geometric Coefficient of Variation 6
|
—
|
70.90 mcg/mL
|
24.10 mcg/mL
|
45.14 mcg/mL
Geometric Coefficient of Variation 3
|
72.20 mcg/mL
|
—
|
—
|
|
Phase 1: Serum Concentrations of Tislelizumab
Cycle 13 Day 1: Pre-dose
|
—
|
—
|
90.00 mcg/mL
|
—
|
51.90 mcg/mL
|
—
|
46.28 mcg/mL
Geometric Coefficient of Variation 4
|
—
|
—
|
—
|
|
Phase 1: Serum Concentrations of Tislelizumab
Cycle 17 Day 1: Pre-dose
|
—
|
—
|
87.90 mcg/mL
|
—
|
—
|
—
|
45.79 mcg/mL
Geometric Coefficient of Variation 3
|
—
|
—
|
—
|
|
Phase 1: Serum Concentrations of Tislelizumab
Cycle 25 Day 1: Pre-dose
|
—
|
—
|
103.00 mcg/mL
|
—
|
—
|
—
|
43.04 mcg/mL
Geometric Coefficient of Variation 10
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 2, 5, 6, 9, 13, 17, 25 and at EOI (within 30 minutes) on Day 1 of Cycles 1 and 5 (each cycle was 21 days)Population: Analysis was performed on PK analysis set. The 'Number Analyzed' = participants with available data at each time point and "0" signifies there were no participants with available data.
Serum concentrations of tislelizumab were measured using an enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=21 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=22 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab
Cycle 13 Day 1: Pre-dose
|
—
|
49.57 mcg/mL
Geometric Coefficient of Variation 47
|
64.20 mcg/mL
|
34.88 mcg/mL
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab
Cycle 17 Day 1: Pre-dose
|
—
|
37.68 mcg/mL
Geometric Coefficient of Variation 60
|
—
|
38.54 mcg/mL
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab
Cycle 25 Day 1: Pre-dose
|
—
|
63.70 mcg/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab
Cycle 1 Day 1: Pre-dose
|
9.09 mcg/mL
Geometric Coefficient of Variation 137
|
10.61 mcg/mL
Geometric Coefficient of Variation 593
|
26.45 mcg/mL
Geometric Coefficient of Variation 125
|
13.57 mcg/mL
Geometric Coefficient of Variation 187
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab
Cycle 1 Day 1: EOI
|
62.51 mcg/mL
Geometric Coefficient of Variation 30
|
77.36 mcg/mL
Geometric Coefficient of Variation 32
|
95.63 mcg/mL
Geometric Coefficient of Variation 69
|
60.27 mcg/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab
Cycle 2 Day 1: Pre-dose
|
20.35 mcg/mL
Geometric Coefficient of Variation 39
|
23.46 mcg/mL
Geometric Coefficient of Variation 84
|
25.92 mcg/mL
Geometric Coefficient of Variation 103
|
19.76 mcg/mL
Geometric Coefficient of Variation 73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab
Cycle 5 Day 1: Pre-dose
|
34.47 mcg/mL
Geometric Coefficient of Variation 61
|
39.51 mcg/mL
Geometric Coefficient of Variation 39
|
35.54 mcg/mL
Geometric Coefficient of Variation 83
|
32.96 mcg/mL
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab
Cycle 5 Day 1: EOI
|
84.82 mcg/mL
Geometric Coefficient of Variation 20
|
102.93 mcg/mL
Geometric Coefficient of Variation 18
|
106.79 mcg/mL
Geometric Coefficient of Variation 76
|
96.71 mcg/mL
Geometric Coefficient of Variation 75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab
Cycle 6 Day 1: Pre-dose
|
28.12 mcg/mL
Geometric Coefficient of Variation 37
|
41.92 mcg/mL
Geometric Coefficient of Variation 47
|
33.02 mcg/mL
Geometric Coefficient of Variation 178
|
32.56 mcg/mL
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Serum Concentrations of Tislelizumab
Cycle 9 Day 1: Pre-dose
|
29.70 mcg/mL
|
45.83 mcg/mL
Geometric Coefficient of Variation 28
|
71.20 mcg/mL
|
39.05 mcg/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: up to 57.5 monthsPopulation: Analysis was performed on ADA analysis set which included all participants who received ≥ 1 dose of study drug and for whom both baseline ADA and ≥ 1 post-baseline ADA results were available. The 'Overall Number of Participants Analyzed' = participants with available data for the analysis.
Immunogenic responses to surzebiclimab included: treatment emergent, treatment-induced and treatment boosted anti-drug antibodies (ADA) and neutralizing antibody (NAb) positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the Baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive Nab at any time including baseline and/or after drug administration.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Anti-Drug Antibodies (ADA) to Surzebiclimab
Treatment-Induced ADAs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase 1: Number of Participants With Anti-Drug Antibodies (ADA) to Surzebiclimab
Treatment-Boosted ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase 1: Number of Participants With Anti-Drug Antibodies (ADA) to Surzebiclimab
Treatment-Emergent ADAs
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase 1: Number of Participants With Anti-Drug Antibodies (ADA) to Surzebiclimab
NAb Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study in Cohort B: up to 21.5 monthsPopulation: Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.
Immunogenic responses to surzebiclimab included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In) Cohort B: Number of Participants With Anti-Drug Antibodies to Surzebiclimab
Treatment-Boosted ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In) Cohort B: Number of Participants With Anti-Drug Antibodies to Surzebiclimab
Treatment-Emergent ADAs
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In) Cohort B: Number of Participants With Anti-Drug Antibodies to Surzebiclimab
Treatment-Induced ADAs
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In) Cohort B: Number of Participants With Anti-Drug Antibodies to Surzebiclimab
NAb Positive ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 monthsPopulation: Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.
Immunogenic responses to surzebiclimab included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=18 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=21 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=19 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Surzebiclimab
Treatment-Boosted ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Surzebiclimab
Treatment-Emergent ADAs
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Surzebiclimab
Treatment-Induced ADAs
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Surzebiclimab
NAb Positive ADAs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 monthsPopulation: Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.
Immunogenic responses to alcestobart included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Alcestobart
Treatment-Boosted ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Alcestobart
Treatment-Emergent ADAs
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Alcestobart
NAb Positive ADAs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Alcestobart
Treatment-Induced ADAs
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 monthsPopulation: Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.
Immunogenic responses to alcestobart included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=19 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion) Cohorts 4 and 5: Number of Participants With Anti-Drug Antibodies to Alcestobart
Treatment-Emergent ADAs
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion) Cohorts 4 and 5: Number of Participants With Anti-Drug Antibodies to Alcestobart
Treatment-Induced ADAs
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion) Cohorts 4 and 5: Number of Participants With Anti-Drug Antibodies to Alcestobart
Treatment-Boosted ADAs
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion) Cohorts 4 and 5: Number of Participants With Anti-Drug Antibodies to Alcestobart
NAb-Positive ADAs
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: up to 57.5 monthsPopulation: Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.
Immunogenic responses to tislelizumab included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=1 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=7 Participants
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Anti-Drug Antibodies to Tislelizumab
Treatment-Induced ADAs
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Phase 1: Number of Participants With Anti-Drug Antibodies to Tislelizumab
Treatment-Emergent ADAs
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Phase 1: Number of Participants With Anti-Drug Antibodies to Tislelizumab
Treatment-Boosted ADAs
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Phase 1: Number of Participants With Anti-Drug Antibodies to Tislelizumab
NAb Positive ADAs
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 monthsPopulation: Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.
Immunogenic responses to alcestobart included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=4 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=3 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=6 Participants
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Tislelizumab
Treatment-Emergent ADAs
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Tislelizumab
Treatment-Induced ADAs
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Tislelizumab
Treatment-Boosted ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Phase 2 (Safety Lead-In): Number of Participants With Anti-Drug Antibodies to Tislelizumab
NAb Positive ADAs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 monthsPopulation: Analysis was performed on ADA analysis set. The 'Overall Number of Participants Analyzed' = participants with available data for analysis.
Immunogenic responses to tislelizumab included: treatment-emergent, treatment-induced and treatment-boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive NAb at any time including baseline and/or after drug administration.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=17 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=19 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Tislelizumab
Treatment-Emergent ADAs
|
7 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Tislelizumab
Treatment-Induced ADAs
|
7 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Tislelizumab
Treatment-Boosted ADAs
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Number of Participants With Anti-Drug Antibodies to Tislelizumab
NAb Positive ADAs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 days after last dose of study drug (maximum treatment duration: Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months)Population: Analysis was performed on safety analysis set.
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. Severity of AEs was assessed according to NCI-CTCAE v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Outcome measures
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=21 Participants
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=22 Participants
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=20 Participants
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2 (Dose Expansion): Number of Participants With TEAEs and SAEs
Any TEAE
|
20 Participants
|
21 Participants
|
20 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Number of Participants With TEAEs and SAEs
Grade 3 or above TEAE
|
11 Participants
|
11 Participants
|
9 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 2 (Dose Expansion): Number of Participants With TEAEs and SAEs
Serious TEAE
|
9 Participants
|
8 Participants
|
6 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
Serious events: 1 serious events
Other events: 7 other events
Deaths: 1 deaths
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + Surzebiclimab + Tislelizumab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab
Serious events: 4 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab
Serious events: 9 serious events
Other events: 20 other events
Deaths: 15 deaths
Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab
Serious events: 8 serious events
Other events: 20 other events
Deaths: 11 deaths
Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
Serious events: 6 serious events
Other events: 20 other events
Deaths: 11 deaths
Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
Serious events: 9 serious events
Other events: 20 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=1 participants at risk
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=1 participants at risk
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=3 participants at risk
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 participants at risk
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=7 participants at risk
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 participants at risk
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=7 participants at risk
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 participants at risk
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
n=1 participants at risk
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of cycle 1, and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
n=1 participants at risk
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of cycle 1, and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab
n=4 participants at risk
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab
n=6 participants at risk
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab
n=6 participants at risk
Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + Surzebiclimab + Tislelizumab
n=3 participants at risk
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab
n=6 participants at risk
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab
n=6 participants at risk
Participants received alcestobart 900 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab
n=21 participants at risk
Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab
n=22 participants at risk
Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
n=20 participants at risk
Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
n=20 participants at risk
Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Autoimmune myocarditis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Asthenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Disease progression
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
General physical health deterioration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Multiple organ dysfunction syndrome
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Oedema peripheral
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Troponin I increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Troponin T increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated arthritis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.1%
2/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Immune-mediated encephalopathy
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
13.6%
3/22 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal obstruction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord dysfunction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
Other adverse events
| Measure |
Phase 1 (Dose Escalation): Surzebiclimab 2 mg + Tislelizumab
n=1 participants at risk
Participants received surzebiclimab 2 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab
n=1 participants at risk
Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab
n=3 participants at risk
Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab
n=5 participants at risk
Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab
n=7 participants at risk
Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab
n=4 participants at risk
Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab
n=7 participants at risk
Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab
n=3 participants at risk
Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 60 mg
n=1 participants at risk
Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of cycle 1, and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 1 (Dose Escalation): Surzebiclimab 1600 mg
n=1 participants at risk
Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of cycle 1, and discontinued the study treatment. Cycle 1 consisted of 28 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab
n=4 participants at risk
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab
n=6 participants at risk
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab
n=6 participants at risk
Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + Surzebiclimab + Tislelizumab
n=3 participants at risk
Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab
n=6 participants at risk
Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab
n=6 participants at risk
Participants received alcestobart 900 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab
n=21 participants at risk
Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab
n=22 participants at risk
Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
n=20 participants at risk
Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab
n=20 participants at risk
Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
6/21 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
13.6%
3/22 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
35.0%
7/20 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
30.0%
6/20 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Endocrine disorders
Autoimmune hypothyroidism
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
4/20 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Blepharitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Cataract
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Dry eye
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Eye pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Macular oedema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Retinal exudates
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Uveitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Visual impairment
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
42.9%
3/7 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
50.0%
2/4 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
15.0%
3/20 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Ascites
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
27.3%
6/22 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
66.7%
2/3 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
2/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
50.0%
2/4 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
50.0%
3/6 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
6/21 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
13.6%
3/22 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
5/20 • Number of events 8 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
15.0%
3/20 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Malignant ascites
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
66.7%
2/3 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
50.0%
2/4 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
2/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
66.7%
2/3 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
50.0%
3/6 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
23.8%
5/21 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
22.7%
5/22 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
15.0%
3/20 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
5/20 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
2/7 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
75.0%
3/4 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Asthenia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
15.0%
3/20 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
30.0%
6/20 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Axillary pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Catheter site inflammation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Chest pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Cyst
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Facial pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
50.0%
2/4 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
42.9%
3/7 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
57.1%
12/21 • Number of events 13 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
27.3%
6/22 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
4/20 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
15.0%
3/20 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Generalised oedema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Hunger
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Localised oedema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Nodule
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Oedema peripheral
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
50.0%
2/4 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.1%
2/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Peripheral swelling
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Supraclavicular fossa pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
General disorders and administration site conditions
Swelling
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
COVID-19
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
2/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Impetigo
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Lymph node abscess
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Otitis media
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Paronychia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Skin infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Systemic viral infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
3/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Collateral circulation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Hot flush
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Radiation fibrosis - lung
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
2/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
13.6%
3/22 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Amylase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
2/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
13.6%
3/22 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
2/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.1%
2/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.1%
2/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Blood potassium increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
3/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Blood urea increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Grip strength decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Lipase increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
2/7 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
4/20 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
5/20 • Number of events 9 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Thyroxine free increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Troponin I increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Troponin T increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
Weight decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
66.7%
2/3 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Investigations
White blood cell count increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
50.0%
2/4 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
66.7%
2/3 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
3/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.1%
2/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
4/20 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
5/20 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.1%
2/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperalbuminaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.1%
2/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.1%
2/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
15.0%
3/20 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
7/21 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
4/20 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
19.0%
4/21 • Number of events 6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
100.0%
1/1 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
7/21 • Number of events 11 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
4/20 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
60.0%
3/5 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
2/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
42.9%
3/7 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.1%
2/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
4/20 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.1%
2/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Bone swelling
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
28.6%
2/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
100.0%
1/1 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
15.0%
3/20 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoural oedema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour exudation
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.1%
2/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
4/20 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
13.6%
3/22 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
3/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
13.6%
3/22 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
15.0%
3/20 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
4/20 • Number of events 4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
3/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
27.3%
6/22 • Number of events 7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
4/20 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity pneumonitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
3/21 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
15.0%
3/20 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
14.3%
1/7 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
9.5%
2/21 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
4/20 • Number of events 5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
20.0%
1/5 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
2/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
15.0%
3/20 • Number of events 3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.8%
1/21 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
10.0%
2/20 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
4.5%
1/22 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Jugular vein distension
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
5.0%
1/20 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 2 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
25.0%
1/4 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
16.7%
1/6 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/5 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/7 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/3 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/4 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
33.3%
1/3 • Number of events 1 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/6 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/21 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/22 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
0.00%
0/20 • All cause-mortality data was collected from randomization through end of study (up to 6 years 3 months). SAEs & nonserious AEs data: up to 30 days after last dose of study drugs (Maximum treatment duration: up to 32.7 months [Phase 1]; Cohort A: up to 19.6 months; Cohort B: up to 21.5 months [Phase 2 Safety Lead-In] and Cohort 1: up to 6.9 months, Cohort 2: up to 23.5 months, Cohort 4: up to 9.6 months, Cohort 5: up to 15.4 months [Phase 2 Dose Expansion])
Analysis was performed on safety analysis set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER